Actively Recruiting
Application of the Belle.AI Dermatological Image Reference System for Patient Diagnosis in an Active Clinical Setting
Led by BelleTorus Corporation · Updated on 2024-12-09
263
Participants Needed
1
Research Sites
41 weeks
Total Duration
On this page
Sponsors
B
BelleTorus Corporation
Lead Sponsor
U
Urban Health Plan Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Application of the Belle.AI Dermatological Image Reference System for Patient Diagnosis in an Active Clinical Setting
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Urban Health Plan Inc.
The Bronx, New York, United States, 07059
Actively Recruiting
Research Team
J
John Romano, MD
CONTACT
F
Franco Barsanti, PharmD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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