What is the Belle AI study studying for skin conditions?

This study is evaluating an AI-powered image reference tool designed to help primary care providers diagnose skin conditions. It compares diagnoses made with the AI tool against those from expert dermatologists to understand the tool's usefulness in routine care. The research is sponsored by BelleTorus Corporation to advance AI support in dermatology.

Who may be eligible for this skin condition clinical trial?

Adults and children who have a primary dermatological complaint and access to a smartphone with internet may qualify. Participants must be willing to provide consent and follow study procedures. Pediatric patients with genital skin conditions are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this skin condition clinical trial?

Study-related care, including use of the AI app and all trial visits, is provided at no cost. However, personal travel expenses or other costs may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

All Genders

ID06724627

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

Research Sites

13 weeks

Total Duration

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

All Genders

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.

Research Team

John Romano, MD

Franco Barsanti, PharmD

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