Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2026-01-22 @ 8:18 AM
Study NCT ID:
NCT07243093
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-11-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validating and AI Software for Assessment of Children With Ear Concerns
Sponsor:
Glimpse Diagnostics, Inc.
Organization:
Study Overview
Official Title:
Validating a Deep Learning Algorithm in Children With Ear Concerns
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R44EB036883-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |