Clinical Evaluation of the OtoSight
Completed
- Conditions
- Otitis Media
- Interventions
- Device: OtoSight Middle Ear Scope
- Registration Number
- NCT03890107
- Lead Sponsor
- PhotoniCare, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pediatric tympanostomy tube patients OtoSight Middle Ear Scope Patients diagnosed with otitis media and scheduled for tympanostomy tube placement will be imaged with the OtoSight
- Primary Outcome Measures
Name Time Method OtoSight imaging exam 1-5 minutes Optical coherence tomography imaging to evaluate the middle ear.
- Secondary Outcome Measures
Name Time Method Adverse events Date of recruitment (day of surgery) to post-operative follow-up visit (approx. 1 month, but can be longer) Rate of adverse events
Trial Locations
- Locations (2)
Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
Children's National Health System
🇺🇸Washington, District of Columbia, United States