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

NCT07025473 | Not Yet Recruiting DMC

• 2 other identifiers: 138884675N91023C00045
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ear Infection

Keywords

AI; Artificial Intelligence; Digital Health; Ear Disorders; Otoscopy; Digital Videoscope; Ear Health

Outcome Measures

Primary Outcomes (2)

• Accuracy of Belle AI Image References

  Comparison of Belle AI's image reference system primary probability diagnosis to the reference diagnosis established by the medical review committee; additional evaluation of the accuracy of the second and third highest probability diagnoses determined by the Bell Image Match Score.

  Through study completion, an average of 14 days

• Provider-Rated Usefulness

  Primary care providers' rating of the usefulness of the Belle AI in supporting the assessment of middle ear conditions utilizing an exit survey where higher scores are more favorable than lower scores.

  Through study completion, an average of 14 days

Secondary Outcomes (2)

• Agreement between diagnoses

  Through study completion, an average of 14 days

• Cost-Impact Analysis

  Through study completion, an average of 14 days

Other Outcomes (1)

• Protocol Adherence

  Through study completion, an average of 14 days

Study Arms (1)

Standard of care

OTHER

Standard of care

Diagnostic Test: Smartphone-enabled otoscopy

Interventions

Smartphone-enabled otoscopy DIAGNOSTIC_TEST

Belle AI for ear image assessment

Standard of care

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patient must be aged 1 to 17 years old.
• Patient must present with a primary middle ear complaint.
• Parent of the pediatric 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 the provided off-the-shelf otoscope for the required image capture.

You may not qualify if:

• Patients who are unable to comply with study procedures due to physical or mental health limitations (as assessed by study coordinator).

Sponsors & Collaborators

• BelleTorus Corporation: lead

Study Sites (1)

Urban Health Plan, Inc.

The Bronx, New York, 10459, United States

Location

Related Links

• Description AI for ear image assessment
• Bronx, Queens and Harlem-based clinics serving 83,000 patients

MeSH Terms

Conditions

Otitis; Ear Diseases

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Diseases

Central Study Contacts

Franco Barsanti, PharmD

CONTACT

+1 (347) 446-0227; franco.barsanti@urbanhealthplan.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A panel of board-certified otolaryngologists will review all medically relevant information for each study participant to establish the gold standard by reviewing ear images captured by the primary care providers using smartphone camera and otoscope. Study will measure how primary care providers move closer to the gold standards with the support of AI image assessment. The study also measure impact on health equity by enabling at-home, remote assessment of ear images capture by the patient smartphone and a low-cost otoscope, followed by assessment of AI for provider review.

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: June 17, 2025
• Study Start: June 30, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)