An observational study in Otitis Media Acute, sponsored by PhotoniCare, Inc.. Completed at 1 site in United States. Open to participants aged 6 Months to 4 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-23.
Sponsored by PhotoniCare, Inc. · Observational
The objective of this study is to clinically develop and evaluate a machine learning approach to improve the performance and data interpretation of the PhotoniCare OtoSight Middle Ear Scope in pediatric patients presenting at the primary care office for suspected ear infections. In this observational study, results of OtoSight imaging will not affect patient standard of care.
241 studies on the registry are indexed under Otitis Media; 32 are open to participants now.
This study's enrollment of 188 is above the median of 150 across 57 observational studies indexed under Otitis Media.
Browse Otitis Media studies →PhotoniCare, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children presenting to the pediatric clinic with suspected ear infection
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pediatric patients presenting with otitis media (acute otitis media or otitis media with effusion) will be imaged with the PhotoniCare OtoSight.
Device: PhotoniCare OtoSight Middle Ear Scope
PhotoniCare OtoSight imaging using a near-infrared laser
PhotoniCare OtoSight imaging exam
Optical coherence tomography imaging to evaluate the middle ear.
Time frame: 1-5 minutes; at first and only study visit
Adverse events
Rate of adverse events
Time frame: 15-30 minutes; at first and only study visit
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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PhotoniCare, Inc.