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Evaluating Laser Otoscope for Middle Ear Effusion Detection
Sponsor: MSTATT LLC
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.
Official title: Evaluation of an Investigational Laser Otoscope for Detection of Middle Ear Effusion in Pediatric Patients
Key Details
Gender
All
Age Range
6 Months - 18 Years
Study Type
OBSERVATIONAL
Enrollment
150
Start Date
2026-03-01
Completion Date
2026-09-01
Last Updated
2026-03-06
Healthy Volunteers
No
Conditions
Interventions
Laser otoscope examination
Patients will have short videos taken of their tympanic membranes under white light and laser illumination.
Locations (1)
The Cleveland Clinic Foundation
Cleveland, Ohio, United States