Clinical Trial

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

Study acronym: Otoscopy AI
Not Yet Recruiting
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Record status
This record was last updated June 17, 2025 (before its estimated September 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Trial Details
NCT Number NCT07025473
Lead Sponsor BelleTorus Corporation
Conditions Ear Infection
Enrollment 20 participants
Start Date 2025-06-30
Primary Completion 2025-09-30 (estimated)
Study Completion 2025-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-06-17