AI Tool for Skin Conditions

Palo Alto (17 mi)

Overseen byJohn Romano, MD

Age: Any Age

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Recruiting

Sponsor: BelleTorus Corporation

No Placebo Group

Trial Summary

What is the purpose of this trial?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 considered a medical device, similar to a Google image search, which returns similar looking images for reference purposes. For intervention, they healthcare providers use their own training and clinical judgement to make the diagnosis, and not the AI.

Eligibility Criteria

This trial is for primary care providers who diagnose skin conditions. It's designed to see if an AI-powered dermatology image reference app can help them in their assessments. Providers must use their medical judgement, not the AI, to make diagnoses.

Treatment Details

The study tests an investigational AI tool that provides reference images of skin conditions via a smartphone app. The effectiveness of this tool will be compared with the diagnosis accuracy of expert dermatologists.

1Treatment groups

Experimental Treatment

Group I: Standard of careExperimental Treatment1 Intervention

Standard of care