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

NCT06724627 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 263

Last updated 2024-12-09

No results posted yet for this study

Summary

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

  • Skin Condition
  • Dermatology
  • Dermatology/Skin - Other

Interventions

DIAGNOSTIC_TEST

Dermatology/Skin - Other

Belle AI for skin image assessment.

Sponsors & Collaborators

  • Urban Health Plan Inc.

    collaborator UNKNOWN

  • BelleTorus Corporation

    lead INDUSTRY

Principal Investigators

  • John Romano, MD · BelleTorus Corporation

  • Franco Barsanti, PharmD · Urban Health Plan Inc.

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-16
Primary Completion
2025-03-30
Completion
2025-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06724627 on ClinicalTrials.gov