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

ConditionEar Infection
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-17
SponsorBelleTorus Corporation

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Smartphone-enabled otoscopy

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators