Trials / Completed
CompletedNCT03890107
Clinical Evaluation of the OtoSight
Clinical Evaluation of a New Middle Ear Diagnostic to Support FDA Regulatory Clearance
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 110 (actual)
- Sponsor
- PhotoniCare, Inc. · Industry
- Sex
- All
- Age
- 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | OtoSight Middle Ear Scope | OtoSight imaging using a near-infrared laser |
Timeline
- Start date
- 2019-04-15
- Primary completion
- 2021-04-30
- Completion
- 2022-04-30
- First posted
- 2019-03-26
- Last updated
- 2023-05-22
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03890107. Inclusion in this directory is not an endorsement.