Study identification

PURI

https://redirect.ema.europa.eu/resource/108432

EU PAS number

EUPAS108167

Study ID

108432

Official title and acronym

Pilot study for the clinical validation of an artificial intelligence algorithm to optimize the appropriateness of dermatology referrals. (LEGIT.HEALTH_DAO_Derivation_O_2022)

DARWIN EU® study

No

Study countries

Spain

Study description

This study addresses challenges in primary care related to skin disease diagnosis. Discordant diagnoses between primary care physicians and dermatologists are common, exacerbated by a shortage of dermatologists, particularly in less populous areas. The reliance on patient self-reporting introduces potential bias. To overcome these challenges, the study proposes the use of Computer-Aided Diagnosis (CAD) systems, leveraging artificial intelligence for image interpretation and classification. The primary aim is to clinically validate a software designed by Legit.Health for grading disease activity in patients. The objective is to enhance the reliability and precision of skin disease assessment and referral criteria. The ultimate goal is to bridge the gap in dermatological care between primary care providers and specialized dermatology services, leading to improved patient outcomes. The study focuses on adult patients (≥ 18 years) with skin pathologies in the primary care service of health centers referring to Cruces and Basurto University Hospitals. It adopts a prospective observational analytical study design of a longitudinal clinical case series. The specified number of subjects for the study is 400. However, as of the report, only 51 patients have been recruited from various health centers. The initiation date was April 7th, 2022, and the completion date is pending, with an estimated duration of 4 months. This includes 2 months for recruitment, 1 month for specialist photo review, and 1 month for data analysis. The study will remain active until the specified number of recruited patients is reached. The primary objective is to validate the device as a tool for improving the adequacy of referrals to dermatology. Secondary objectives include validating the device's impact on reducing costs in secondary care, decreasing dermatology waiting lists, and optimizing clinical flow in Osakidetza.

Study status

Ongoing
Research institutions and networks

Institutions

Contact details

Jesús Gardeazabal-García

Primary lead investigator
ORCID number:
0000-0001-5938-0835
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
National competent authority (NCAs)
Other

More details on funding

Medtech Initiative from the Basque Government
Study protocol
Initial protocol

LEGIT.HEALTH_DAO_Protocol_Derivation_O_2022 v_2_0_EN-7346a43466f324337201eedc879a759f

English (2.97 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable