Actively Recruiting
Application of the Belle.AI Dermatological Image Reference System on Patient Diagnosis Within an Active Clinical Setting
Led by BelleTorus Corporation · Updated on 2024-12-09
263
Participants Needed
1
Research Sites
13 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
Researchers are evaluating a new artificial intelligence (AI) tool designed to assist primary care providers in assessing skin conditions. This AI-powered dermatology image reference app works with a smartphone to provide reference images, helping providers make diagnoses using their medical training. The study aims to compare diagnoses made by primary care providers using the AI tool to those of a panel of dermatologists, considered the gold standard. The research is supported by the Advanced Research Projects Agency for Health (ARPA-H) and focuses on improving diagnostic accuracy and care in real-world clinical settings. The study involves primary care providers using the Belle AI tool, which analyzes images captured via a smartphone app and identifies over 2,000 skin conditions based on a large image database. Providers use the app during patient visits to capture images and receive differential diagnoses, which they review before making final decisions. After the initial visit, participants receive notifications to submit follow-up images using the app over a two-week period. Providers reassess diagnoses based on updated AI analysis, and follow-up visits may be scheduled or canceled depending on results. Providers receive training on the app and give feedback through surveys. Participants present with a primary dermatological complaint and consent to study procedures, including using the smartphone app to submit images. Researchers monitor diagnosis accuracy compared to a dermatology review committee consensus and assess economic impact and provider experience. The study lasts about 14 days per participant, with ongoing documentation in electronic medical records and continuous case review to determine care needs or resolution.
CONDITIONS
Brief 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.
- Pediatric, adolescent, and teen patients with dermatological conditions on their genitalia are excluded to protect privacy.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 1
At the initial clinic visit, participants’ skin conditions are examined by providers who use the Belle AI system to assist diagnosis by capturing images and generating differential diagnoses.
1 initial clinic visit (in-person)
Duration - Day 7 to Day 14-18
Participants submit images of their skin condition using the Belle Image Capture App starting 7 days after enrollment, with reminders and follow-ups to ensure compliance. Providers reassess diagnoses based on updated AI analysis.
Multiple app submissions prompted by push notifications and coordinator follow-up
Duration - Day 14 to Day 18
Participants may have a follow-up appointment scheduled about two weeks after the initial visit to reassess the condition, though some visits may be cancelled based on AI analysis. Final images or follow-up visits conclude the study participation.
1 follow-up visit (in-person), if scheduled
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
F
Franco Barsanti, PharmD
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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