Application of the Belle.AI Comparative Image Reference System for Describing Chronic Ear Infections in Pediatric Patients From Low-Resource Communities
Smartphone-enabled otoscopy: Belle AI for ear image assessment
Study 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.
Eligibility
Sex
ALL
Min age
1 Year
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
• Patients who are unable to comply with study procedures due to physical or mental health limitations (as assessed by study coordinator).
Primary outcome measure(s)
Accuracy of Belle AI Image References — Through study completion, an average of 14 days 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.
Provider-Rated Usefulness — Through study completion, an average of 14 days 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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