Validating and AI Software for Assessment of Children With Ear Concerns
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-6
SponsorGlimpse Diagnostics, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males and females aged 6 months to 6 years
Presenting to a pediatrician's office or urgent care with signs and symptoms of otitis media, including tugging at ears, ear pain, crying at night, refusing to lie flat, sleeping poorly, having a fever, having decreased appetite, and/or concern for hearing loss, regardless of previous diagnosis of AOM or OME.
Disqualifiers
History of craniofacial abnormality
PE tubes currently in place
Current otorrhea
Caretaker not having use of both hands and arms
Trial population
Children aged 6 months to 6 years presenting with ear concerns
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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 officeLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Glimpse Diagnostics, Inc.
Lead sponsor
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Collaborator
Clinical Research Strategies
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: