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NOT YET RECRUITING
NCT07454512

Evaluating Laser Otoscope for Middle Ear Effusion Detection

Sponsor: MSTATT LLC

View on ClinicalTrials.gov

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

Interventions

DEVICE

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