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Application of the Belle.AI Dermatological Image Reference System for Patient Diagnosis in an Active Clinical Setting

RecruitingNAAges any - anyAllBelleTorus Corporation
NCT06724627 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this research study is to test a new, investigational tool that uses artificial intelligence (AI) to help primary care providers assess skin conditions. This tool is an AI-powered dermatology image reference app that works with a smartphone. For clarity, the AI makes no diagnoses; it provides reference images. Primary care providers then use their own medical judgement and training to make the diagnosis. The sponsor aims to compare the diagnoses made by primary care providers (such as doctors, nurse practitioners, and physician assistants) with the support of the AI tool compared to a panel of dermatologists, who are setting the gold standard. By doing so, the sponsor can determine the value of the AI tool for primary care providers and understand how it might be used alongside traditional clinical care. This AI capability complies with FDA regulatory guidelines and is not

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patient must present to walk-in clinic with a primary dermatological complaint. * Patient must have the ability and willingness to provide informed consent and comply with study procedures and visits. * Participants must have access to the required technology (e.g., smartphone with internet access) and be capable of using it for the required image capture. Exclusion Criteria: * Patients who are unable to comply with study procedures due to physical or mental health limitations (as assessed by study coordinator). * Pediatric, adolescent, and teen patients who present with dermatological conditions on their genitalia will not be included in the study (in support of patient privacy concerns).
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What it tests

  • Dermatology/Skin - Other
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Where

1 site
Urban Health Plan Inc.
The Bronx, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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