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.
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.
None
Single group
Smartphone-enabled otoscopy
Diagnostic testBelle AI for ear image assessment
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.
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.
Agreement between diagnoses
Agreement between HCPs and the AI system and its effect on accuracy and utility ratings
Cost-Impact Analysis
A partial cost-impact analysis will be conducted based on the system's effectiveness in diagnosing otitis media.
Protocol Adherence
Separate analyses for per-protocol and intent-to-treat populations to understand adherence effects.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
