R-TF-015-006 Clinical investigation report
Research Title
Clinical investigation of the clinical utility, data utility, usability and patient satisfaction associated with the device for remote monitoring of chronic dermatological conditions at a hospital dermatology department.
Nature and positioning of the evidence
This is a prospective, observational, single-arm clinical investigation on real adult patients attending a hospital dermatology department. Under MDCG 2020-6 Appendix III it constitutes Rank 2–4 evidence. Under MDCG 2020-1 §4.4 it contributes Pillar 3 Clinical Performance evidence — specifically evidence of clinical utility, data utility, usability and patient satisfaction associated with the clinician+device remote-monitoring workflow — and does not, on its own, evidence algorithm-level analytical performance across the intended 346 ICD-11 categories (Pillar 2) nor substitute for diagnostic-accuracy evidence generated on the Top-5 prioritised differential view (evidenced by the Rank 2–4 diagnostic-performance investigations listed in the Clinical Evaluation Report).
Product identification
| Information | |
|---|---|
| Device name | Legit.Health Plus (hereinafter, the device) |
| Model and type | NA |
| Version | 1.1.0.0 |
| Basic UDI-DI | 8437025550LegitCADx6X |
| Certificate number (if available) | MDR 000000 (Pending) |
| EMDN code(s) | Z12040192 (General medicine diagnosis and monitoring instruments - Medical device software) |
| GMDN code | 65975 |
| EU MDR 2017/745 | Class IIb |
| EU MDR Classification rule | Rule 11 |
| Novel product (True/False) | TRUE |
| Novel related clinical procedure (True/False) | TRUE |
| SRN | ES-MF-000025345 |
Throughout this document, references to "the device" refer to the investigational product identified above.
Device version under investigation and bridging to the CE-marked release
The device version under investigation corresponds to the current CE-marked release v1.1.0.0. The PRRC has reviewed the device change-control records covering the investigation window (April 2022 – October 2023) and confirms that, in relation to the CIP objectives, variables and acceptance criteria, the configuration used during the investigation is equivalent to the current CE-marked release (identity bridge). No clinically relevant change in intended purpose, indications for use, algorithm-level clinical output, user interface mandated by the Instructions for Use, or risk profile was introduced between the investigation window and the current release.
Identification of sponsors
- Hospital Universitario de Torrejón.
- Ribera Salud S.A.
- Sponsor of record and legal manufacturer of the investigational device: AI Labs Group S.L. (contact details held within the QMS).
Identification of the Clinical Investigation Plan (CIP)
| CIP | |
|---|---|
| Title of the clinical investigation | Clinical Validation of a Computer-Aided Diagnosis (CAD) System Utilizing Artificial Intelligence Algorithms for Continuous and Remote Monitoring of Patient Condition Severity in an Objective and Stable Manner |
| Device under investigation | Legit.Health Plus |
| Protocol version | Version 2.0 |
| Date | 2022-03-03 |
| Protocol code | LEGIT_COVIDX_EVCDAO_2022 |
| Sponsor | AI Labs Group S.L. |
| Coordinating Investigator | Dra. Marta Andreu |
| Principal Investigator(s) | Dra. Marta Andreu |
| Investigational site(s) | Torrejón University Hospital |
| Ethics Committee | Comité de Ética de la Investigación con Medicamentos de los Hospitales Universitarios Torrevieja y Elche-Vinalopó |
Trial Registrations
- ClinicalTrials.gov (NCT): NCT06237036.
- EMA RWD Catalogue (EUPAS): EUPAS108260.
Public Access Database
A public-facing results summary is (or will be) made available through the registry entries listed under Trial Registrations. The underlying subject-level data are not publicly accessible due to privacy and data-protection requirements.
Research Team
Principal investigator
- Dr. Marta Andreu Barasoain (Hospital Universitario de Torrejón).
Collaborating Investigators
- Dr. Leticia Calzado — Chief of Dermatology, Hospital Universitario de Torrejón.
- Dr. Elena Sánchez-Largo — Attending Dermatology Physician, Hospital Universitario de Torrejón.
- Dr. Javier Alcántara — Attending Dermatology Physician, Hospital Universitario de Torrejón.
- Dr. Tania Marusia Capusan — Attending Dermatology Physician, Hospital Universitario de Torrejón.
- Dr. Marta Ruano — Attending Dermatology Physician, Hospital Universitario de Torrejón.
Technical Support (Manufacturer)
- Mr. Alfonso Medela — Chief Technology Officer.
- Mr. Taig Mac Carthy — Chief Innovation Officer.
Investigational site
- Department of Dermatology, Hospital Universitario de Torrejón.
Compliance Statement
The clinical investigation will be conducted according to the Clinical Investigation Plan (CIP) and other applicable guidances and regulations. This includes compliance with:
- The ethical principles originating from the
World Medical Association's Declaration of Helsinki - Harmonized standard
UNE-EN ISO 14155:2020 Regulation (EU) 2017/745 on medical devices (MDR), including the applicableGeneral Safety and Performance Requirements (GSPR)as outlined in Annex I, and the requirements ofAnnex XV(Chapter I and Chapter II, Section 3)- Harmonized standard
UNE-EN ISO 13485:2016 MDCG 2024-3for its structural and content expectations,MDCG 2021-8concerning application requirements, andMDCG 2020-10/1 Rev 1for safety reporting timelines and definitionsRegulation (EU) 2016/679(GDPR)- Spanish
Organic Law 3/2018on the Protection of Personal Data and guarantee of digital rights.
All data processing within the device is carried out in accordance with the highest standards of data protection and privacy. Patient information is managed in an encrypted manner to ensure confidentiality and security.
The research team assumes the role of Data Controller, responsible for the collection and management of study data. Legit.Health acts as the Data Processor and is not involved in the processing of patient data.
The storage and transfer of data comply with European data protection regulations. At the conclusion of the study, all information stored in the device will be permanently and securely deleted.
The device employs robust technical and organizational security measures to safeguard personal data against unauthorized access, alteration, loss, or processing.
Report Date
October 17, 2023.
Report author(s)
The full name, the ID and the signature for the authorship, as well as the approval process of this document, can be found in the verified commits at the repository. This information is saved alongside the digital signature, to ensure the integrity of the document.
Table of contents
Table of contents
- Research Title
- Product identification
- Identification of sponsors
- Identification of the Clinical Investigation Plan (CIP)
- Public Access Database
- Research Team
- Compliance Statement
- Report Date
- Report author(s)
- Table of contents
- Abbreviations and Definitions
- Summary
- Introduction
- Materials and methods
- Results
- Analysis
- Discussion and Overall Conclusions
- Investigators and administrative structure of the clinical research
- Report annexes
Abbreviations and Definitions
- AE: Adverse Event
- AEMPS: Spanish Agency of Medicines and Medical Devices
- AEP: Adverse Reaction to Product
- AUC: Area Under the ROC Curve
- CAD: Computer-Aided Diagnosis
- CMD: Data Monitoring Committee
- CIP: Clinical Investigation Plan
- CUS: Clinical Utility Questionnaire
- DLQI: Dermatology Quality of Life Index
- GCP: Standards of Good Clinical Practice
- ICH: International Conference of Harmonization
- IFU: Instructions For Use
- IRB: Institutional Review Board
- N/A: Not Applicable
- NCA: National Competent Authority
- PI: Principal Investigator
- PPV: Positive Predictive Value
- NPV: Negative Predictive Value
- SAE: Serious Adverse Events
- SAEP: Serious Adverse Event to Product
- SUAEP: Serious and Unexpected Adverse Event to the Product
- SUS: System Usability Scale
Summary
Title
Clinical investigation of the clinical utility, data utility, usability and patient satisfaction associated with the device for remote monitoring of chronic dermatological conditions at a hospital dermatology department.
Pre-specified acceptance-criteria structure
The pre-specified acceptance-criteria set for this investigation is the domain-structured set rendered by the <AcceptanceCriteriaTable /> component below and in §Discussion → Clinical performance. Each criterion is anchored to a State-of-the-Art baseline established in R-TF-015-011 State of the Art and is tested against its own pre-specified threshold. The seven criteria span three clinical-utility domains: objective severity assessment (two criteria), expert consensus (one criterion), and resource optimisation (four criteria, including a Clinical Utility Questionnaire (CUS)-acronymed criterion at the 0.80 substantial-clinical-benefit threshold).
Introduction
This clinical investigation evaluates, in a real-world hospital dermatology setting, the clinical utility, data utility, usability and patient satisfaction associated with the device when used by patients at home for self-capture of images and self-completed severity questionnaires, and by dermatologists for remote review of the resulting records. A cohort of 160 adult patients was enrolled at the Dermatology Department of the Hospital Universitario de Torrejón; 6 dermatologists participated as investigator-raters. The investigation was conducted under prior favourable opinion of the competent Ethics Committee for Research with Medicinal Products and in accordance with applicable data-protection requirements.
Objectives
Primary objective
To evaluate the clinical utility of the device, as perceived by attending dermatologists, for remote and continuous monitoring of chronic dermatological conditions. The primary endpoint is the pre-specified acceptance-criteria set rendered by the <AcceptanceCriteriaTable /> component; each criterion is tested against its own pre-specified threshold; the aggregate outcome is reported as the count of met and not-met criteria, qualified by domain.
Secondary objectives
- To assess investigator-rated data utility via the Data Utility Questionnaire (DUQ).
- To assess system usability via the System Usability Scale (SUS) questionnaire.
- To assess patient-reported satisfaction via the Patient Satisfaction Questionnaire.
All secondary endpoints are descriptive and hypothesis-generating.
- CUS (Expert consensus) equal to or greater than 75.00%.(User Group: Dermatologists)
- Expert consensus between range 75.00%.(User Group: Dermatologists)
- CUS (Expert consensus) equal to or greater than 80.00%.(User Group: Dermatologists)
Population
The investigation enrolled adult patients attending the Dermatology Department of the Hospital Universitario de Torrejón with a chronic dermatological condition meeting the inclusion criteria.
Sample size
The investigation enrolled 6 participating dermatologists and 160 patients. The investigator-reported clinical-utility instruments (CUS, DUQ) are assessed on the n = 6 dermatologist cohort; the patient-reported instruments (Patient Satisfaction Questionnaire, SUS completed by patients) are assessed on the n = 160 patient cohort. The small dermatologist cohort limits the statistical power of inferential tests at the individual-criterion level; this constraint is carried forward in §Limitations and in the Post-Market Clinical Follow-up Plan.
Design and Methods
Design
The investigation proceeded as follows.
1. Patient selection and recruitment visit
The recruitment period spanned six months, during which the investigators identified eligible patients attending the Dermatology Department.
The Principal Investigator, or a designated collaborating investigator, explained the study details to potential participants using the Patient Information Sheet. Patients had the opportunity to seek clarification on any aspects of the investigation.
Patients who agreed to participate provided written informed consent and received a study code. Data capture commenced post-consent. During the initial visit, patients used the device under the supervision of the research team to complete the baseline questionnaires and to capture photographs associated with their condition.
Subsequently, each patient autonomously and remotely continued data capture at home, as detailed in the following section.
The device was provided at no cost to patients and to the research team for the study's duration.
2. Procedures performed by the patient at home
2.1. Completion of questionnaires
Patients independently reported their condition from home, following instructions provided by the research team and the Patient Information Guide distributed during the screening visit.
At regular intervals, patients documented the status of their condition using questionnaires and the Dermatology Life Quality Index (DLQI), integrated into the device, in conjunction with photograph submissions. The full question wording is provided in Appendix IV and Appendix V of the protocol.
Every two months, patients completed the Patient Satisfaction Questionnaire, addressing general user-experience aspects. They also completed the System Usability Scale (SUS) questionnaire at the same frequency. The full question wording is provided in Appendix II and Appendix III of the protocol.
2.2. Image capture
Patients took photographs of the affected areas while completing questionnaires through the device's application. Photographs were captured using the patient's own smartphone from their home in an autonomous manner. The frequency of photograph submission was determined by the consulting specialist. No specialised camera equipment was required.
Patients then transmitted these photographs to the research team through a secure, access-controlled web-based component of the device. Both patients and members of the medical team held individual authenticated accounts.
The manufacturer did not have access to patient accounts or personal data. Data transfer and photograph storage adhered to Regulation (EU) 2016/679 (GDPR) and the Spanish Organic Law 3/2018 on the Protection of Personal Data and Guarantee of Digital Rights.
Number of subjects
A total of 160 patients were enrolled in this investigation.
Initiation and completion dates
- Initiation date: April 13, 2022.
- Completion date: October 23, 2023.
Duration
The investigation spanned a total duration of 18 months, encompassing the time needed for database closure and editing, data analysis and preparation of the final study report after the recruitment of the last subject.
Methods
The investigation employed a prospective, observational, single-arm design to evaluate the clinical utility, data utility, usability and patient satisfaction associated with the device in remote monitoring of chronic dermatological conditions. Data capture involved investigator-completed clinical-utility and data-utility questionnaires, patient-submitted photographs and self-completed severity questionnaires, and patient-reported satisfaction and usability questionnaires. The investigation adhered to applicable ethical and data-protection requirements. The primary endpoint is the pre-specified acceptance-criteria set described in §Pre-specified acceptance-criteria structure; secondary analyses are descriptive.
Results
Four of the seven pre-specified acceptance criteria were met at their State-of-the-Art-anchored thresholds.
- Met — Objective severity assessment, two criteria: CUS-acronymed severity-assessment endorsement at 0.80 (threshold ≥ 0.75); secondary severity-assessment endorsement at 0.83 (threshold ≥ 0.75).
- Met — Expert consensus, one criterion: 1.00 (threshold ≥ 0.75).
- Met — Resource optimisation, one criterion: 1.00 (threshold ≥ 0.75).
- Not met — Resource optimisation, three criteria: an equal-to-or-greater-than criterion at 0.67 (threshold ≥ 0.75); a within-range criterion at 0.50 (pre-specified acceptance range around 0.75); the CUS-acronymed resource-optimisation criterion at 0.7667 (threshold ≥ 0.80; one-sample descriptive t-test against µ0 = 0.80, p = 0.56).
No adverse events or product-related reactions were reported during the investigation via the AE-collection mechanism described in §Adverse events and adverse reactions to the product. Descriptive secondary analyses of item-level CUS, DUQ, SUS and Patient Satisfaction Questionnaire scores are reported in §Analysis.
Conclusions
Four of seven pre-specified acceptance criteria were met at their State-of-the-Art-anchored thresholds. Both objective-severity-assessment criteria and the expert-consensus criterion were met; one of four resource-optimisation criteria was met. The three unmet criteria are all in the resource-optimisation domain: a within-range criterion at 0.50, an equal-to-or-greater-than criterion at 0.67 and the CUS-acronymed resource-optimisation criterion at 0.7667 (threshold 0.80; the associated one-sample descriptive test against µ0 = 0.80 returned p = 0.56).
Under MDCG 2020-1 §4.4, the investigation contributes Pillar 3 Clinical Performance supporting evidence at Rank 2–4 for the clinical-utility, data-utility, usability and patient-satisfaction aspects of the clinician+device remote-monitoring workflow. The severity-assessment and expert-consensus domain findings support clinical-utility claims within those domains. Resource-optimisation findings are mixed; the Post-Market Clinical Follow-up Plan (R-TF-007-002) commits to independent-sample confirmation of the unmet resource-optimisation criteria with a larger dermatologist cohort.
No claim of diagnostic-accuracy performance is made on the basis of this investigation; diagnostic-accuracy evidence is generated by the diagnostic-performance investigations listed in the Clinical Evaluation Report (R-TF-015-003).
Benefit-risk assessment against GSPR 1 and GSPR 8
GSPR 1 (benefits outweigh risks): four of seven pre-specified acceptance criteria — two severity-assessment criteria, the expert-consensus criterion and one resource-optimisation criterion — were met at their State-of-the-Art-anchored thresholds. The three unmet criteria, all in the resource-optimisation domain, are tracked to the Post-Market Clinical Follow-up Plan for confirmatory follow-up. The absence of reported adverse events or product-related reactions via the investigation's AE-collection mechanism, combined with the non-interventional observational use of the device in this investigation, supports a favourable residual-risk profile consistent with the device's intended use as a remote-monitoring adjunct. The broader benefit-risk determination for the device is addressed at Clinical Evaluation level, where this investigation is one of several Pillar 3 §4.4 supporting sources.
GSPR 8 (use-error risk minimisation): the primary use-error risk associated with a remote-monitoring workflow of this type is misinterpretation of the device output as a diagnostic determination. This risk is mitigated by the Instructions for Use, which frame the device as decision-support only and which mandate integration requirements — including the Top-5 prioritised differential, the malignancy gauge and the referral recommendation — for every downstream interface; by the clinician's retained final decision-making; and by the non-interventional nature of the investigation itself, in which device output did not replace standard of care. No use-related serious adverse event was reported via the AE-collection mechanism described in §Adverse events.
The quantified residual-risk numerics associated with the device's algorithm-level analytical performance are reported in the diagnostic-performance investigations and in R-TF-013-002 Risk Management Record; they are not re-derived from this investigation.
Introduction
This clinical investigation evaluates, in a real-world hospital dermatology setting, the clinical utility, data utility, usability and patient satisfaction associated with the device when used for remote monitoring of chronic dermatological conditions.
The investigation is prospective, observational and single-arm. Under MDCG 2020-6 Appendix III it constitutes Rank 2–4 evidence; under MDCG 2020-1 §4.4 it contributes Pillar 3 Clinical Performance supporting evidence for the clinician+device remote-monitoring workflow. It does not, on its own, evidence algorithm-level analytical performance across the intended 346 ICD-11 categories (Pillar 2) nor substitute for diagnostic-accuracy evidence generated on the Top-5 prioritised differential view (evidenced by the Rank 2–4 diagnostic-performance investigations listed in the Clinical Evaluation Report).
The investigation enrolled 160 adult patients attending the Dermatology Department of the Hospital Universitario de Torrejón and 6 participating dermatologists. The Clinical Investigation Plan pre-specified a seven-criterion clinical-utility acceptance set (rendered by the <AcceptanceCriteriaTable /> component and anchored to the State-of-the-Art baselines established in R-TF-015-011) as the primary endpoint, supplemented by descriptive secondary analyses of item-level CUS, DUQ, SUS and Patient Satisfaction Questionnaire scores.
The Results, Analysis, Discussion and Conclusions sections present the findings of this investigation in accordance with the pre-specified analysis plan.
Materials and methods
Product Description
This section contains a short summary of the device. A complete description of the intended purpose, including device description, can be found in the record Legit.Health Plus description and specifications.
Product description
The device is a computational software-only medical device leveraging computer vision algorithms to process images of the epidermis, the dermis and its appendages, among other skin structures. Its principal function is to provide a wide range of clinical data from the analyzed images to assist healthcare practitioners in their clinical evaluations and allow healthcare provider organisations to gather data and improve their workflows.
The generated data is intended to aid healthcare practitioners and organizations in their clinical decision-making process, thus enhancing the efficiency and accuracy of care delivery.
The device should never be used to confirm a clinical diagnosis. On the contrary, its result is one element of the overall clinical assessment. Indeed, the device is designed to be used when a healthcare practitioner chooses to obtain additional information to consider a decision.
Intended purpose
The device is a computational software-only medical device intended to support health care providers in the assessment of skin structures, enhancing efficiency and accuracy of care delivery, by providing:
- quantification of intensity, count, extent of visible clinical signs
- interpretative distribution representation of possible International Classification of Diseases (ICD) categories.
Intended previous uses
No specific intended use was designated in prior stages of development.
Product changes during clinical research
The device maintained a consistent performance and features throughout the entire clinical research process. No alterations or modifications were made during this period.
Clinical Investigation Plan
Objectives
This investigation evaluates:
- The pre-specified clinical-utility acceptance-criteria set rendered by the
<AcceptanceCriteriaTable />component (primary endpoint; seven criteria across three domains: objective severity assessment, expert consensus, resource optimisation). - The data utility of the device, via the investigator-rated DUQ (secondary, descriptive).
- The system usability of the device, via the SUS questionnaire (secondary, descriptive).
- Patient-reported satisfaction with the device, via the Patient Satisfaction Questionnaire (secondary, descriptive).
Study design (type of research, assessment criteria, methods)
This is a prospective, observational, single-arm investigation. There is no active arm and no control arm. The primary endpoint is the multi-criterion clinical-utility acceptance set described above; secondary analyses are descriptive. Assessment instruments include the CUS, DUQ, SUS and Patient Satisfaction Questionnaire. Data capture includes investigator-completed questionnaires, patient-submitted photographs and patient-reported outcomes.
Ethical considerations
Ethics Committee Approval
Approved by the Comité de Ética de la Investigación con Medicamentos de los Hospitales Universitarios Torrevieja y Elche-Vinalopó on 2022-04-13, reference number 12/04/22 LEGIT_COVIDX.
This study adhered to international Good Clinical Practice (GCP) guidelines, the Declaration of Helsinki in its latest amendment, and applicable international and national regulations. As applicable, approval from the relevant Ethics Committee was obtained prior to the initiation of the study. When applicable, modifications to the protocol were reviewed and approved by the Principal Investigator (PI) and subsequently evaluated by the Ethics Committee before subjects were enrolled under a modified protocol.
This study was conducted in compliance with European Regulation 2016/679, of 27 April, concerning the protection of natural persons with regard to the processing of personal data and the free movement of such data (General Data Protection Regulation, GDPR), and Organic Law 3/2018, of 5 December, on the Protection of Personal Data and the guarantee of digital rights. In accordance with these regulations, no data enabling the personal identification of participants was collected, and all information was managed securely in an encrypted format.
Participants were informed both orally and in writing about all relevant aspects of the study, with the information being tailored to their level of understanding. They were provided with a copy of the informed consent form and the accompanying patient information sheet. Adequate time was given to patients to ask questions and fully comprehend the details of the study before providing their consent.
The PI was responsible for the preparation of the informed consent form, ensuring it included all elements required by the International Conference on Harmonisation (ICH), adhered to current regulatory guidelines, and complied with the ethical principles of GCP and the Declaration of Helsinki.
The original signed informed consent forms were securely stored in a restricted access area under the custody of the PI. These documents remained at the research site at all times. Participants were provided with a copy of their signed consent form for their records.
Data confidentiality
Current legislation will be complied with in terms of data confidentiality protection (European Regulation 2016/679, of 27 April, on the protection of natural persons with regard to the processing of personal data and the free movement of such data and Organic Law 3/2018, of 5 December, on Personal Data Protection and guarantee of digital rights). For this purpose, when applicable, each participant will receive an alphanumeric identification code in the study that will not include any data allowing personal identification (coded CRD). The Principal Investigator will have an independent list that will allow the connection of the identification codes of the patients participating in the study with their clinical and personal data. This document will be filed in a secure area with restricted access, under the custody of the Principal Investigator and will never leave the centre.
Once the paper CRDs are completed and closed by the Principal Investigator, the data will be transferred to a database.
As in the CRDs, the Database will comply with current legislation in terms of data confidentiality protection (European Regulation 2016/679, of 27 April, on the protection of natural persons about the processing of personal data and the free movement of such data and Organic Law 3/2018, of 5 December, on the Protection of Personal Data and guarantee of digital rights) in which no data allowing personal identification of patients will be included.
Data Quality Assurance
The Principal Investigator is responsible for reviewing and approving the protocol, signing the Principal Investigator commitment, guaranteeing that the persons involved in the centre will respect the confidentiality of patient information and protect personal data, and reviewing and approving the final study report together with the sponsor. All the clinical members of the research team assess the eligibility of the patients in the study, inform and request written informed consent, collect the source data of the study in the clinical record and transfer them to the Data Collection Notebook (DCN) or Data Collection Forms (CRF).
Subject Population
The investigation enrolled 160 adult patients attending the Dermatology Department of the Hospital Universitario de Torrejón. The enrolled patients carried a range of chronic dermatological conditions. Distribution by ICD-11 category is detailed below.
| ICD-11 category | Number of patients |
|---|---|
| Acne | 67 |
| Haemangioma | 14 |
| Hidradenitis suppurativa | 8 |
| Actinic keratosis | 5 |
| Rosacea | 4 |
| Nevus | 4 |
| Contact dermatitis | 4 |
| Psoriasis | 4 |
| Folliculitis | 3 |
| Atopic dermatitis | 3 |
| Keratosis palmaris et plantaris | 3 |
| Seborrheic keratosis | 3 |
| Eczema | 3 |
| Lichen planus | 2 |
| Prurigo nodularis | 2 |
| Psoriasis palms soles | 2 |
| Malignant melanoma | 2 |
| Factitial dermatitis | 2 |
| Basal cell carcinoma | 2 |
| Pustulosis palmaris et plantaris | 1 |
| Melasma | 1 |
| Scar | 1 |
| Sebaceous gland hyperplasia | 1 |
| Seborrheic dermatitis | 1 |
| Squamous cell carcinoma | 1 |
| Pityriasis lichenoides | 1 |
| Non-specific lesion | 1 |
| Tinea corporis | 1 |
| Venous leg ulcer | 1 |
| Acanthosis nigricans | 1 |
| Intertrigo | 1 |
| Leukonychia | 1 |
| Keratoderma palmaris et plantaris | 1 |
| Irritant contact dermatitis | 1 |
| Infestations and insect bites | 1 |
| Herpes | 1 |
| Hematoma | 1 |
| Guttate psoriasis | 1 |
| Fibroma | 1 |
| Epidermoid cyst | 1 |
| Confluent and reticulated papillomatosis | 1 |
| Chondrodermatitis nodularis | 1 |
| Cellulitis | 1 |
| Carcinoma (unspecified) | 1 |
| Angioma | 1 |
| Alopecia areata | 1 |
| Vitiligo | 1 |
Some patients presented with more than one diagnosis, contributing to the total count. The CIP named eight specific chronic dermatological conditions (psoriasis, urticaria, hidradenitis suppurativa, acne, atopic dermatitis, vitiligo, infantile haemangioma and nail pathology) as the focal conditions of interest; the inclusion criteria did not, however, operationally restrict enrolment to those eight conditions. The enrolled cohort therefore includes additional chronic dermatological diagnoses attended by the Dermatology Department, together with a small number of malignancy diagnoses (2 malignant melanoma, 2 basal cell carcinoma, 1 squamous cell carcinoma, 5 actinic keratosis and 1 unspecified carcinoma) encountered during routine attendance. This enrolment pattern is declared as a deviation in §Deviations from the Clinical Investigation Plan and its impact on the primary and secondary analyses is discussed in that section.
Inclusion criteria
- Adult patients (>18 years) attending the Dermatology Department of the Hospital Universitario de Torrejón with a chronic dermatological condition.
- Patients who have provided written informed consent for participation in the investigation.
- Patients who demonstrate proficiency in written and spoken Spanish or English.
- Patients who possess a smartphone, defined as a phone equipped with internet access and an integrated camera, regardless of make, model or technical specifications.
Exclusion criteria
- Patients who, as determined by the investigator, are unable to adhere to the investigational procedures.
- Patients who had used the device under investigation prior to the commencement of the study.
Treatment
Patients participating in this investigation did not receive any specific treatment as part of the research protocol.
Concomitant medication and treatment
Patients continued their regular prescribed medications and treatments as directed by their primary healthcare providers. No additional medications or treatments were administered as part of this investigation.
Follow-up duration
The follow-up period was 6 months per participant. During this period, patients underwent a minimum of two follow-up visits, which could be conducted either remotely or in person, in accordance with the study protocol.
The Principal Investigator or designated collaborating investigators administered the Patient Satisfaction Questionnaire (Appendix II) and the System Usability Scale (Appendix III) to patients. The Principal Investigator or designated collaborating investigators also completed the Clinical Utility Questionnaire (Appendix I) as required by the study protocol.
Statistical Analysis
The primary analysis is the assessment of each of the seven pre-specified acceptance criteria against its own threshold, as rendered by the <AcceptanceCriteriaTable /> component. For each criterion, the observed value is compared against the pre-specified threshold per the valence declared in the acceptance-criteria data (equal-to-or-greater-than, within-range); the criterion is reported as met or not met. The aggregate primary-endpoint outcome is the count of met versus not-met criteria, qualified by domain.
Two-sided 95% Wilson confidence intervals are reported for the observed values on each criterion. Where a CUS-acronymed criterion is reported, a one-sample Student's t-test against the pre-specified threshold is reported as descriptive inferential support at α = 0.01; this inferential support is supplementary and does not displace the acceptance-criteria-based decision rule.
Secondary descriptive analyses report means, standard deviations and, where applicable, two-sided 95% Wilson confidence intervals for proportions. No formal multiplicity control is applied; all secondary analyses are pre-specified as descriptive and hypothesis-generating.
The analysis is implemented in a deterministic, version-controlled analytics environment maintained by the manufacturer; statistical tests and confidence intervals are computed in accordance with the Statistical Analysis section of the CIP.
Performance claims cross-reference
studyCode or folderSlug prop, or ensure this component is used within an Investigation document with a registered folder slug.Results
Initiation and completion dates
- Initiation date: April 13, 2022.
- Completion date: October 23, 2023.
Subject disposition and accountability
400 patients were screened at the Dermatology Department against the CIP inclusion and exclusion criteria during the recruitment window. 240 were excluded at screening. 160 patients met the pre-specified eligibility criteria, provided written informed consent and were enrolled. All 160 enrolled patients completed at least one post-baseline data-capture cycle and are included in the descriptive secondary analyses on the patient-reported instruments. All 6 participating dermatologists returned a completed CUS and a completed DUQ; 6 dermatologists returned a completed SUS. Categorised reasons for screen-failure at the 240 excluded patients are retained in the screening and enrolment log held by the Principal Investigator; categories include inability to provide informed consent, lack of a smartphone meeting the inclusion criterion, investigator-determined inability to adhere to the investigational procedures, and prior use of the device under investigation.
Subject-level data accountability was maintained through individual authenticated accounts on the device's secure, access-controlled web-based component. Version provisioning and session logging were controlled by the manufacturer under the QMS; subjects interacted only with the investigational device version documented in §Product identification and its Device version under investigation and bridging to the CE-marked release subsection.
Subject demographics
The investigation did not use age or nationality as primary stratification variables. The enrolled cohort encompasses a diverse patient population with a range of chronic dermatological conditions.
- Sex: men 63 (39.6%), women 97 (60.4%).
| Fitzpatrick phototype | Count | Percentage |
|---|---|---|
| Phototype I | 79 | 49.3% |
| Phototype II | 62 | 38.5% |
| Phototype III | 17 | 10.9% |
| Phototype IV | 2 | 1.3% |
| Phototype V | 0 | 0.0% |
| Phototype VI | 0 | 0.0% |
The enrolled cohort includes no Fitzpatrick V or VI participants and only 2 Fitzpatrick IV participants. Accordingly, this investigation does not, on its own, support performance claims on Fitzpatrick IV, V or VI skin tones; phototype coverage for darker skin tones is addressed by dedicated phototype-bridging evidence at Clinical Evaluation level (R-TF-015-003) and by the Post-Market Clinical Follow-up Plan (R-TF-007-002).
Clinical Investigation Plan (CIP) Compliance
The deviations from the Clinical Investigation Plan identified during the course of this investigation are listed below. All deviations are assessed as not affecting subject safety; their impact on the primary and secondary analyses is discussed on an individual basis.
Deviations from the Clinical Investigation Plan
Deviation 1: extended study duration
- Planned duration: 12 months total (6 months recruitment + 6 months analysis and reporting).
- Actual duration: 18 months (April 13, 2022 – October 23, 2023).
- Reason: the recruitment period extended beyond the planned 6 months due to slower-than-expected enrolment rate at the investigational site. Upon achievement of the target sample size of 160 patients the investigation was concluded.
- Impact: no impact on subject safety or on the validity of the pre-specified analyses; the extended window allowed completion of the target enrolment.
- Approval: the Ethics Committee (Comité de Ética de la Investigación con Medicamentos de los Hospitales Universitarios Torrevieja y Elche-Vinalopó) was formally notified of the timeline adjustment and remained informed throughout the extended recruitment period.
Deviation 2: off-protocol enrolment of pathologies outside the CIP condition-of-interest list
- Planned condition of interest: eight specific chronic dermatological conditions (psoriasis, urticaria, hidradenitis suppurativa, acne, atopic dermatitis, vitiligo, infantile haemangioma, nail pathology).
- Actual enrolment: the enrolled cohort covers a broader range of ICD-11 chronic dermatological diagnoses attended by the Dermatology Department, including a small number of malignancy diagnoses (2 malignant melanoma, 2 basal cell carcinoma, 1 squamous cell carcinoma, 5 actinic keratosis, 1 unspecified carcinoma).
- Reason: the CIP inclusion criteria did not operationally restrict enrolment to the condition-of-interest list, and the investigational site applied the inclusion criteria as written during consecutive attendance.
- Impact: the primary endpoint (the seven-criterion clinical-utility acceptance set) is a clinician-rated and patient-rated clinical-utility assessment of the device across the cohort as a whole and is not restricted to any single pathology; the primary-endpoint computation is therefore unchanged by the broader enrolment. No disease-specific claim is made on the basis of this investigation. Specifically, no diagnostic-accuracy claim, no sensitivity/specificity claim and no severity-monitoring claim is made for the malignancy diagnoses included in the cohort.
- Approval: documented in this Clinical Investigation Report; no retroactive Ethics Committee approval is sought because the deviation concerns the condition-of-interest characterisation, not the pre-specified inclusion and exclusion criteria or the consent process.
Deviation 3: Question 5 scoring rule applied at analysis
- Planned scoring (CIP): CUS Question 5 scored on the 0–10 normalised common scale applied to the other CUS items.
- Applied scoring (analysis): CUS Question 5 responses indicating "I have not reduced time" scored as 0; responses indicating any reduction in consultation time scored as 100 (equivalent to 10 on the 0–10 scale), regardless of the magnitude of the reported reduction.
- Reason: to provide a binary summary of whether a consultation-time reduction was reported on that specific item, consistent with the binary-scored CUS items Q2, Q6 and Q10.
- Impact on the primary endpoint: the Q5 rescoring affects the item-level contribution of Q5 to any aggregation that includes it and, in particular, affects the denominator used for the CUS-acronymed resource-optimisation criterion (NVT; achieved 0.7667 against a threshold of 0.80). The directional conclusion for this criterion (not met at a narrow margin) is insensitive to the scoring choice: reconstruction of the criterion under the original CIP Likert scoring for Q5 does not move the achieved value above the 0.80 threshold. The other six acceptance criteria do not incorporate Q5 and are unaffected.
- Approval: documented in this Clinical Investigation Report; the scoring rule is a post-hoc analysis choice disclosed alongside the acceptance-criteria outcomes.
Acceptance-criteria outcomes
The pre-specified acceptance-criteria set was assessed against its seven State-of-the-Art-anchored thresholds as rendered by the <AcceptanceCriteriaTable /> component. Four of the seven criteria were met; three — all in the resource-optimisation domain — were not met.
Met (4 of 7):
- Objective severity assessment, CUS-acronymed: observed 0.80 against an SotA-anchored threshold ≥ 0.75.
- Objective severity assessment, secondary: observed 0.83 against an SotA-anchored threshold ≥ 0.75.
- Expert consensus: observed 1.00 against an SotA-anchored threshold ≥ 0.75.
- Resource optimisation, equal-to-or-greater-than criterion: observed 1.00 against an SotA-anchored threshold ≥ 0.75.
Not met (3 of 7), all in the resource-optimisation domain:
- Resource optimisation, equal-to-or-greater-than criterion: observed 0.67 against an SotA-anchored threshold ≥ 0.75.
- Resource optimisation, within-range criterion: observed 0.50 against the pre-specified acceptance range around 0.75.
- Resource optimisation, CUS-acronymed: observed 0.7667 against a substantial-clinical-benefit threshold ≥ 0.80; the associated one-sample descriptive t-test against µ0 = 0.80 returned p = 0.56 (null hypothesis µ < 0.80 not rejected).
The aggregate primary-endpoint outcome is therefore: severity-assessment domain — both criteria met; expert-consensus domain — met; resource-optimisation domain — mixed (one of four criteria met). The CUS-acronymed resource-optimisation criterion (which corresponds to the CIP narrative headline "score of 8 or higher on the Clinical Utility Questionnaire") was not met at a narrow margin; confirmatory follow-up on the unmet resource-optimisation criteria is committed to the Post-Market Clinical Follow-up Plan (R-TF-007-002).
Analysis
Primary analysis
As reported in §Acceptance-criteria outcomes, four of the seven pre-specified acceptance criteria were met at their State-of-the-Art-anchored thresholds. The per-criterion observed values, thresholds and pass/fail adjudications are rendered by the <AcceptanceCriteriaTable /> component in §Discussion → Clinical performance.
Item-level descriptive analyses (supporting)
The item-level item-mean tables below support the acceptance-criteria outcomes by describing the underlying response distributions on each validated instrument. They do not constitute a confirmatory test in their own right.
Clinical Utility Questionnaire (CUS) — item means
Item-level means and standard deviations on a 0–10 normalised scale are reported below. Question 5 is scored per the binary rule declared in §Deviation 3 above; Questions 2, 6 and 10 are binary-scored per the CIP.
| Question # | Mean | Standard Deviation |
|---|---|---|
| 2 | 6.67 | 5.16 |
| 3 | 8.67 | 0.82 |
| 4 | 7.00 | 2.00 |
| 5 | 5.00 | 5.48 |
| 6 | 10.00 | 0.00 |
| 7 | 6.50 | 3.62 |
| 8 | 7.33 | 2.42 |
| 9 | 5.50 | 2.43 |
| 10 | 10.00 | 0.00 |
| 11 | 6.67 | 2.34 |
| 12 | 8.00 | 1.26 |
| 13 | 7.33 | 1.51 |
Item-level observations supporting the met severity-assessment and expert-consensus acceptance criteria include unanimous agreement on Q3 (ease of use, 8.67/10), Q6 (time optimisation, 10/10), Q10 (data-collection enhancement, 10/10) and Q12 (general satisfaction ≥ 7/10 across all participating dermatologists). The full question wording is provided in Appendix I of the protocol.
Data Utility Questionnaire (DUQ)
The Data Utility Questionnaire was completed by all 6 participating specialists.
- Item 1 (usefulness of the application): unanimous agreement on the usefulness of an application to facilitate regular practice.
- Item 2 (severity identification): 5/6 agreed on the usefulness of an application to identify case severity; 1/6 slightly disagreed.
- Item 3 (teleconsultation data capture): 4/6 agreed that an application to collect patient data during teleconsultations would be beneficial.
- Item 4 (treatment prescription): mixed opinions — 1/3 totally agreed, 1/3 agreed, 1/3 slightly agreed.
- Item 5 (patient follow-up): 5/6 totally agreed on the usefulness of an application for patient follow-up; 1/6 slightly agreed.
Item-level DUQ mean scores and standard deviations (on a 0–5 scale) are reported below.
| Question # | Mean | Standard Deviation |
|---|---|---|
| 1 | 4.67 | 0.52 |
| 2 | 4.17 | 1.17 |
| 3 | 4.33 | 1.03 |
| 4 | 4.00 | 0.89 |
| 5 | 4.67 | 0.82 |
System Usability Scale (SUS)
The System Usability Scale questionnaire was completed by all 6 participating specialists. Item-level means and standard deviations are reported below on a 0–10 normalised scale.
| Question # | Mean | Standard Deviation |
|---|---|---|
| 1 | 7.67 | 1.97 |
| 2 | 8.00 | 3.10 |
| 3 | 9.00 | 1.10 |
| 4 | 9.33 | 1.03 |
| 5 | 8.00 | 2.19 |
| 6 | 7.67 | 3.20 |
| 7 | 9.67 | 0.82 |
| 8 | 9.67 | 0.82 |
| 9 | 8.33 | 0.82 |
| 10 | 9.67 | 0.82 |
The item-mean SUS scores are reported here on the 0–10 normalised scale. The canonical SUS composite (Brooke, 1996) computed on the 0–100 scale with reverse-scoring of the even-numbered items was not used as a pre-specified endpoint; SUS data are reported at item-mean level so that the canonical composite can be recomputed on the source data if required. The full question wording is provided in Appendix III of the protocol.
Patient Satisfaction Questionnaire
The Patient Satisfaction Questionnaire was completed by enrolled patients (n = 160). Item-level descriptive statistics on a 0–10 scale are reported below.
| Question # | Mean | Standard Deviation |
|---|---|---|
| 1 | 8.10 | 2.13 |
| 2 | 7.32 | 2.87 |
| 3 | 6.52 | 3.17 |
| 4 | 5.45 | 3.01 |
| 5 | 7.35 | 2.89 |
| 6 | 6.55 | 3.36 |
| 7 | 7.55 | 2.49 |
| 8 | 7.77 | 2.75 |
The full question wording is provided in Appendix II of the protocol.
Adverse events and adverse reactions to the product
Adverse events and adverse reactions associated with the use of the device were collected via (i) the investigator-administered visit forms at each scheduled study visit, (ii) a dedicated AE field in the electronic case-report form available to the investigator at any point during the follow-up period, and (iii) a patient-accessible free-text feedback field in the device's application. No adverse events, adverse reactions or serious adverse events related to the investigational product were reported through these mechanisms during the 18-month investigation window and the per-participant 6-month follow-up period.
Product deficiencies
No device deficiencies that could have led to a serious adverse event or adverse device effect were reported during the investigation via the reporting mechanism described in GP-009 Post-Market Surveillance and in the CIP. No corrective actions arising from device deficiencies were required.
Subgroup analysis for special populations
No special-population subgroup analyses were pre-specified and none are reported.
Discussion and Overall Conclusions
Clinical performance, efficacy and safety
Acceptance-criteria pass/fail summary
studyCode or folderSlug prop, or ensure this component is used within an Investigation document with a registered folder slug.Four of the seven pre-specified acceptance criteria were met at their State-of-the-Art-anchored thresholds, as rendered by the table above. The severity-assessment domain (both criteria met) and the expert-consensus domain (met) support clinical-utility claims within those domains. The resource-optimisation domain outcome is mixed (one of four criteria met); the CUS-acronymed resource-optimisation criterion — the criterion that corresponds to the CIP narrative headline "score of 8 or higher on the Clinical Utility Questionnaire" — was not met at a narrow margin (observed 0.7667 against a 0.80 threshold; one-sample descriptive t-test p = 0.56).
The dermatologist sample size (n = 6) limits the statistical power of the inferential support at the individual-criterion level. The Post-Market Clinical Follow-up Plan (R-TF-007-002) commits to an independent-sample confirmation of the unmet resource-optimisation criteria with a larger dermatologist cohort; this confirmatory activity is traced to PMCF.
No adverse events, adverse reactions or serious adverse events related to the investigational product were reported via the AE-collection mechanism described in §Adverse events and adverse reactions to the product, consistent with the non-interventional design and the intended use of the device.
Clinical relevance
This investigation contributes Pillar 3 §4.4 supporting evidence, at Rank 2–4, on the clinical-utility, data-utility, usability and patient-satisfaction aspects of the clinician+device remote-monitoring workflow for chronic dermatological conditions. Four of seven pre-specified acceptance criteria were met at their State-of-the-Art-anchored thresholds — both severity-assessment criteria, the expert-consensus criterion and one of four resource-optimisation criteria. Three resource-optimisation criteria were not met; the unmet criteria are reported honestly, their observed values are rendered in the acceptance-criteria table above, and confirmatory follow-up is committed to the PMCF Plan.
Within the met severity-assessment domain, the investigation supports the device's utility as a clinician-facing decision-support adjunct for patient monitoring: the two severity-assessment criteria were met at 0.80 and 0.83 against the 0.75 SotA threshold. Within the met expert-consensus domain, unanimous agreement among the participating dermatologists (1.00 observed against a 0.75 threshold) supports the device's fit within the hospital dermatology workflow. No diagnostic-accuracy claim is made on the basis of this investigation.
Supporting background literature on AI-based clinical decision support in dermatology [1]–[9] is cited descriptively and does not substitute for device-specific evidence. Device-specific diagnostic-accuracy evidence is generated in the diagnostic-performance investigations listed in the Clinical Evaluation Report (R-TF-015-003); device-specific analytical performance across the intended 346 ICD-11 categories is evidenced independently by the verification-and-validation records and by the published severity-validation manuscripts referenced at Clinical Evaluation level.
References:
[1] Mac Carthy, T., et al. "Automatic Urticaria Activity Score (AUAS): deep learning-based automatic hive counting for urticaria severity assessment." JID Innovations (2023): 100218.
[2] Hernández Montilla, I., et al. "Automatic International Hidradenitis Suppurativa Severity Score System (AIHS4): a novel tool to assess the severity of hidradenitis suppurativa using artificial intelligence." Skin Research and Technology 29.6 (2023): e13357.
[3] Hernández Montilla, I., et al. "Dermatology Image Quality Assessment (DIQA): artificial intelligence to ensure the clinical utility of images for remote consultations and clinical trials." Journal of the American Academy of Dermatology 88.4 (2023): 927–928.
[4] Medela, A., Mac Carthy, T., Aguilar Robles, S. A., Chiesa-Estomba, C. M., Grimalt, R. "Automatic SCOring of atopic dermatitis using deep learning: a pilot study." JID Innovations 2.3 (2022): 100107.
[5] Esteva, A., et al. "Dermatologist-level classification of skin cancer with deep neural networks." Nature 542.7639 (2017): 115–118.
[6] Haenssle, H. A., et al. "Man against machine: diagnostic performance of a deep-learning convolutional neural network for dermoscopic melanoma recognition in comparison to 58 dermatologists." Annals of Oncology 29.8 (2018): 1836–1842.
[7] Han, S. S., et al. "Classification of the clinical images for benign and malignant cutaneous tumors using a deep-learning algorithm." Journal of Investigative Dermatology 138.7 (2018): 1529–1538.
[8] Gomez-Cabello, C. A., et al. "Artificial-intelligence-based clinical decision-support systems in primary care: a scoping review of current clinical implementations." European Journal of Investigation in Health, Psychology and Education 14 (2024): 685–698.
[9] Smith, A. C., et al. "Telehealth for global emergencies: implications for coronavirus disease 2019 (COVID-19)." Journal of Telemedicine and Telecare 26.5 (2020): 309–313.
Specific benefits and precautions
The specific benefit of the device in the remote-monitoring workflow evaluated here is the systematic collection of patient-reported severity data and patient-submitted images between scheduled visits, supporting the dermatologist's longitudinal assessment of chronic dermatological conditions. The device does not replace the dermatologist's clinical judgement and is framed in the Instructions for Use as decision-support only.
Clinicians are reminded that the device's image-analysis output is dependent on image quality; in cases of poor image quality the clinician must rely on clinical judgement and seek additional diagnostic evidence as appropriate. The Instructions for Use mandate integration requirements — including display of the Top-5 prioritised differential, the malignancy gauge and the referral recommendation — for every downstream interface.
Implications for future research
The Post-Market Clinical Follow-up Plan (R-TF-007-002) addresses the following activities that are explicitly outside the scope of this investigation:
- Confirmatory evidence for the three unmet resource-optimisation acceptance criteria on an independent, larger dermatologist cohort.
- Clinical-utility and usability evidence in primary-care and community settings, beyond the hospital dermatology department evaluated here.
- Phototype coverage across Fitzpatrick IV, V and VI skin tones.
- Long-term patient-outcome evidence attributable to the remote-monitoring workflow supported by the device.
- Diagnostic-accuracy evidence associated with the device's Top-5 prioritised differential view, which is generated by the diagnostic-performance investigations listed in the Clinical Evaluation Report.
Limitations of clinical research
- The investigation is single-arm and single-site, limiting generalisability to other clinical settings and to primary-care contexts.
- The dermatologist sample size (n = 6) is small; inferential testing at the individual-criterion level is adequately powered only against large effects and is sensitive to individual outlier responses.
- The primary endpoint is a multi-criterion clinical-utility acceptance set based on clinician- and patient-reported instruments; it measures perceived clinical utility, data utility, usability and resource optimisation. It does not directly evidence diagnostic-accuracy performance or patient-outcome benefit.
- Fitzpatrick V and VI phototype coverage is absent in the enrolled cohort, and Fitzpatrick IV coverage is minimal; the investigation does not, on its own, support performance claims across darker skin tones.
- Patient-submitted photographs are captured on heterogeneous smartphones under uncontrolled lighting; image-quality variability is an expected source of measurement variability.
- The canonical SUS composite (Brooke, 1996) under the canonical reverse-scoring formula was not used as a pre-specified endpoint; SUS data are reported at item-mean level on a 0–10 scale.
- The condition-of-interest characterisation in the CIP named eight specific chronic dermatological conditions; the enrolled cohort is broader. No disease-specific claim is made on the basis of this investigation.
Ethical aspects of clinical research
The investigation was conducted in accordance with applicable international Good Clinical Practice standards and in compliance with the Declaration of Helsinki in its latest active amendment. It also conforms to applicable international and national rules and regulations.
The investigation was approved by the Comité de Ética de la Investigación con Medicamentos de los Hospitales Universitarios Torrevieja y Elche-Vinalopó on 2022-04-13, reference number 12/04/22 LEGIT_COVIDX. No subject was enrolled before the favourable opinion date.
Data handling complies with Regulation (EU) 2016/679 (GDPR) and the Spanish Organic Law 3/2018 on the Protection of Personal Data and Guarantee of Digital Rights. No personal-identifying data are retained in the analysis dataset; all information was managed in an encrypted manner.
Each participant received comprehensive oral and written information about the investigation, tailored to their level of understanding. A copy of the informed-consent form and information sheet was provided to each participant. The investigator ensured that sufficient time was allowed for questions and clarification. Signed informed-consent forms are retained under the custody of the Principal Investigator at the investigational site.
The manufacturer acts as Data Processor under the applicable data-protection instrument; the research team is the Data Controller. The device implements technical and organisational measures consistent with applicable data-protection legislation.
Investigators and administrative structure of the clinical research
Brief description
The investigation was conducted at the Dermatology Department of the Hospital Universitario de Torrejón, with technical support provided by the manufacturer's Chief Technology Officer and Chief Innovation Officer.
Investigators
Principal investigator
- Dr. Marta Andreu Barasoain (Hospital Universitario de Torrejón).
Collaborating Investigators
- Dr. Leticia Calzado — Chief of Dermatology, Hospital Universitario de Torrejón.
- Dr. Elena Sánchez-Largo — Attending Dermatology Physician, Hospital Universitario de Torrejón.
- Dr. Javier Alcántara — Attending Dermatology Physician, Hospital Universitario de Torrejón.
- Dr. Tania Marusia Capusan — Attending Dermatology Physician, Hospital Universitario de Torrejón.
- Dr. Marta Ruano — Attending Dermatology Physician, Hospital Universitario de Torrejón.
Technical Support (Manufacturer)
- Mr. Alfonso Medela — Chief Technology Officer.
- Mr. Taig Mac Carthy — Chief Innovation Officer.
Investigational site
- Department of Dermatology, Hospital Universitario de Torrejón.
External organisation
No additional organisations, beyond those listed above, contributed to the conduct of the investigation.
Sponsor and Monitor
The sponsor and monitor of the investigation is the manufacturer identified under §Identification of sponsors, with Hospital Universitario de Torrejón as the investigational site and Ribera Salud S.A. as the host-group institution.
Report annexes
- Ethics Committee resolution (favourable opinion) retained in the sponsor's trial master file.
- Instructions for Use v1.1.0.0 — available as part of the device's technical file.
- Questionnaires — Appendices I to V of the study protocol.
Signature meaning
The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:
- Author: Team members involved
- Reviewer: JD-018 Clinical Research Coordinator
- Approver: JD-022 Medical Manager