Application of the Belle.AI Comparative Image Reference System for Describing Chronic Ear Infections in Pediatric Patients From Low-Resource Communities

Part of paid clinical trials in The Bronx, New York.

Sponsor
BelleTorus Corporation
Study ID
NCT07025473
Status
Not Yet Recruiting

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Conditions

  • Ear Infection

Eligibility Criteria

Sex
ALL
Age
1 Year - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Smartphone-enabled otoscopy — DIAGNOSTIC_TEST
    Belle AI for ear image assessment

Study Details

The purpose of this research is to examine the clinical effectiveness of an investigational AI-powered smartphone app that describes the physical characteristics of an otoscopy image. It is not intended to make any diagnosis. Only healthcare professionals will make the diagnosis. The investigators will compare the diagnosis made by physicians or physician extenders (healthcare professionals) against the description provided by the support AI app tool to determine the clinical relevance of the system and examine its use within a clinical setting.

Key Dates

Start date
Jun 30, 2025
Status verified
Jun 2025
Primary completion
Sep 30, 2025
Completion
Sep 30, 2025

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Other: Standard of care
    Standard of care

Primary Outcome Measure

Accuracy of Belle AI Image References [ Time Frame: Through study completion, an average of 14 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Urban Health Plan, Inc.The BronxNew York10459
Franco Barsanti, PharmD
[email protected]
+1 (347) 446-0227
Carina Puello, BSN RN
[email protected]
+1 (718) 251-0223
Franco Barsanti, PharmD (PRINCIPAL_INVESTIGATOR)

Find similar trials in The Bronx, NY

By research site
Urban Health Plan, Inc.· The Bronx, NY

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