An observational study in Otalgia, Otitis Media and Otitis Media Effusion, sponsored by Glimpse Diagnostics, Inc.. Not yet recruiting. Open to participants aged 6 Months to 6 Years. Per ClinicalTrials.gov, last updated 2025-11-21.
Sponsored by Glimpse Diagnostics, Inc. · Observational
The goal of this observational study is to determine if the Glimpse machine learning algorithm can accurately assess ear diseases in children. Participants will:
The videos will be used to determine if the Glimpse algorithm matches the diagnosis of the physicians.
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.
284 studies on the registry are indexed under Otitis Media; 33 are open to participants now.
This study's planned enrollment of 658 is above the median of 155 across 72 observational studies indexed under Otitis Media.
Browse Otitis Media studies →This is the only study on the registry with Glimpse Diagnostics, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Children aged 6 months to 6 years presenting with ear concerns
Exclusion Criteria:
Percent agreement of Glimpse machine learning algorithm's classification of a child's ear image with an ENT panel diagnosis
The primary endpoint of this study is to compare the percent agreement of Glimpse machine learning algorithm's classification of a child's ear image with an ENT panel diagnosis of the same child's ear for the diagnoses of acute otitis media (AOM), otitis media with effusion (OME), and no middle ear effusion, versus the percent agreement of primary care provider's (PCP) diagnosis with an ENT panel diagnosis, of in children with otalgia.
Time frame: Within 24 hrs of presenting to PCP or urgent care office
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Earache