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NCT07428941Completed

Evaluating an Artificial Intelligence Tool to Help Primary Care Doctors Diagnose Skin Conditions.

A Multi-Reader Multi-Case (MRMC) Study Assessing the Impact of Legit.Health Plus on the Diagnostic Accuracy and Referral Decision-Making of Primary Care Physicians for Skin Lesions.

Source: ClinicalTrials.gov · Last updated 24 Feb 2026

Brief summary (registry, in English)

This study aims to determine if an artificial intelligence (AI) medical device can help primary care doctors more accurately identify and manage various skin conditions. Skin issues are a frequent reason for doctor visits, but differences in expertise between general practitioners and specialists can sometimes lead to misdiagnoses or unnecessary referrals. The researchers hypothesized that the information provided by the AI device would increase the true diagnostic accuracy of primary care practitioners for multiple dermatological conditions. To test this, the study followed a prospective, self-controlled design where each participating doctor served as their own comparison. During the study, 9 primary care physicians evaluated 30 clinical images representing a variety of skin pathologies. For each image, the doctors followed a two-step process: * First, they provided a diagnosis based only on the image and the patient's medical history. * Second, they were shown the AI's analysis-including the top 5 suggested diagnoses and confidence levels-and asked to provide a final diagnosis. The study also investigated if the AI could help doctors decide whether a patient truly needs a referral to a specialist or if the condition could be handled remotely via teledermatology. The primary question was whether using this AI support would significantly increase the number of correct diagnoses made by primary care doctors and lead to more efficient patient care.

Status (registry)
Completed
Study type
Observational
Enrollment
9 (actual)
First submitted
18 Feb 2026
Start date
Jun 2024
Primary completion date
Sept 2024
Lead sponsor
AI Labs Group S.L
NCT number
NCT07428941

What you commit to

  • Study type: Observational
  • Participants enrolled: 9
  • From Jun 2024 to the primary completion date, Sept 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Low-quality images of patients which can not be properly analyzed.

Who the study is looking for

  • Board-certified primary care physicians regardless of their professional experience.
  • High-quality images of patients with different skin conditions.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
AI Labs Group S.L.
Coordinator of this site? Confirm its status
BilbaoSpainUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.