Trials / Not Yet Recruiting
Not Yet RecruitingNCT07454512
Evaluating Laser Otoscope for Middle Ear Effusion Detection
Evaluation of an Investigational Laser Otoscope for Detection of Middle Ear Effusion in Pediatric Patients
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 150 (estimated)
- Sponsor
- MSTATT LLC · Industry
- Sex
- All
- Age
- 6 Months – 18 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this cross-sectional diagnostic accuracy investigational study is to learn about the usefulness of laser otoscopy in screening for middle ear fluid. The main questions it aims to answer are: -Accuracy and usability of doctors using laser otoscopes Participants already having ear tubes placed will have an examination with a laser otoscope and white light otoscope in order to determine and compare the device's diagnostic assistance. Tympanostomy findings will be used as the ground truth.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Laser otoscope examination | Patients will have short videos taken of their tympanic membranes under white light and laser illumination. |
Timeline
- Start date
- 2026-03-01
- Primary completion
- 2026-07-01
- Completion
- 2026-09-01
- First posted
- 2026-03-06
- Last updated
- 2026-03-06
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07454512. Inclusion in this directory is not an endorsement.