NCT03890107
Completed
Not Applicable
Clinical Evaluation of a New Middle Ear Diagnostic to Support FDA Regulatory Clearance
ConditionsOtitis Media
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Otitis Media
- Sponsor
- PhotoniCare, Inc.
- Enrollment
- 110
- Locations
- 2
- Primary Endpoint
- OtoSight imaging exam
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The objective of this study is to evaluate the imaging capabilities and image analysis performance of the OtoSight Middle Ear Scope in pediatric patients undergoing tympanostomy tube placement for otitis media. In this observational study, results of OtoSight imaging will not affect patient standard of care.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Children (17 years old or younger) scheduled for tympanostomy tube placement
Exclusion Criteria
- •Otoscopy contra-indicated or not possible per attending physician's decision
Outcomes
Primary Outcomes
OtoSight imaging exam
Time Frame: 1-5 minutes
Optical coherence tomography imaging to evaluate the middle ear.
Secondary Outcomes
- Adverse events(Date of recruitment (day of surgery) to post-operative follow-up visit (approx. 1 month, but can be longer))
Study Sites (2)
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