RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-09-16
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06724627

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient must present to walk-in clinic with a primary dermatological complaint.
  2. * Patient must have the ability and willingness to provide informed consent and comply with study procedures and visits.
  3. * 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.
  1. * Patients who are unable to comply with study procedures due to physical or mental health limitations (as assessed by study coordinator).
  2. * 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).

Contacts and Locations

Study Contact

John Romano, MD
CONTACT
617-520-4730
jromano@belle.ai
Franco Barsanti, PharmD
CONTACT
347-446-0227
franco.barsanti@urbanhealthplan.org

Principal Investigator

John Romano, MD
PRINCIPAL_INVESTIGATOR
BelleTorus Corporation
Franco Barsanti, PharmD
STUDY_DIRECTOR
Urban Health Plan Inc.

Study Locations (Sites)

Urban Health Plan Inc.
Bronx, New York, 07059
United States

Collaborators and Investigators

Sponsor: BelleTorus Corporation

  • John Romano, MD, PRINCIPAL_INVESTIGATOR, BelleTorus Corporation
  • Franco Barsanti, PharmD, STUDY_DIRECTOR, Urban Health Plan Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-16
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2024-09-16
Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

  • AI
  • Artificial Intelligence
  • Digital Health
  • Health Equity
  • Dermatology
  • Skin Health

Additional Relevant MeSH Terms

  • Skin Condition
  • Dermatology
  • Dermatology/Skin - Other