NCT07243093

Validating and AI Software for Assessment of Children With Ear Concerns

Validating a Deep Learning Algorithm in Children With Ear Concerns

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 658 (estimated)
• Sponsor: Glimpse Diagnostics, Inc. · Industry
• Sex: All
• Age: 6 Months – 6 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to determine if the Glimpse machine learning algorithm can accurately assess ear diseases in children. Participants will: * Have a video of their ear taken by their parent or their guardian * Have a video of their ear taken by a Primary Care Physician (PCP) * Have an assessment of their eardrums and a video of their ears taken by an Ear, Nose, and Throat specialist (ENT). The videos will be used to determine if the Glimpse algorithm matches the diagnosis of the physicians.

Detailed description

Ear complaints, including earache (otalgia), are the most common reasons children seek healthcare and routinely bring children into the office of a pediatrician or urgent care setting. This study will assess children who present with signs and symptoms of otitis media to the primary care office or urgent care. Participants will receive their standard of care from their treating physician, with study assessments including videos of their ears taken by their parent or guardian and the treating physician. Once this is complete, participants will see an ENT for an assessment of their eardrum. The ENT assessment will occur within 24 hours of the PCP visit and will not be used to inform patient treatment.

Conditions

• Otalgia
• Otitis Media
• Otitis Media Effusion

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-06-01
• Completion: 2027-07-01
• First posted: 2025-11-21
• Last updated: 2025-11-21