Evaluating Laser Otoscope for Middle Ear Effusion Detection

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
MSTATT LLC
Study ID
NCT07454512
Status
Not Yet Recruiting

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Conditions

  • Middle Ear Effusion
  • Otitis Media

Eligibility Criteria

Sex
ALL
Age
6 Months - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Laser otoscope examination — DEVICE
    Patients will have short videos taken of their tympanic membranes under white light and laser illumination.

Study Details

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.

Key Dates

Start date
Mar 1, 2026
Status verified
Mar 2026
Primary completion
Jul 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: Investigational cohort
    Pediatric patients 6 months to 18 years who have been scheduled for tympanostomy and ear tube placement.

Primary Outcome Measure

Clinician diagnostic accuracy using laser otoscope to assess middle ear effusion presence [ Time Frame: From enrollment to data collection at tympanostomy typically at 2-3 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
The Cleveland Clinic FoundationClevelandOhio44106
John O'Neill
[email protected]
216-445-8175
Brandon Hopkins, M.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Cleveland, OH

By research site
The Cleveland Clinic Foundation· Cleveland, OH

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