Evaluating Laser Otoscope for Middle Ear Effusion Detection

March 2, 2026 updated by: MSTATT LLC

Evaluation of an Investigational Laser Otoscope for Detection of Middle Ear Effusion in Pediatric Patients

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • The Cleveland Clinic Foundation
        • Contact:
        • Principal Investigator:
          • Brandon Hopkins, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients ages 6 months to 18 years who are scheduled to undergo unilateral or bilateral myringotomy with ear tube placement (tympanostomy) as part of their standard clinical care. Eligible participants will be identified prior to surgery based on clinical scheduling and medical history.

Description

Inclusion Criteria:

  • Scheduled to undergo unilateral or bilateral myringotomy with ear tube placement
  • Between the ages of 6 months to 18 years at the time of consent
  • Able to provide assent as judged by the investigator or delegated personnel, and their parent(s) or legal guardian(s) has signed the current Institutional Review Board (IRB) approved informed consent form along with the HIPAA Authorization for the use and release of Private Health Information (PHI) or applicable privacy protection

Exclusion Criteria:

  • History of prior ear tube placement
  • Anatomical abnormalities of the tympanic membrane or ear canal
  • Presence of excessive cerumen that cannot be removed pre-exam and may interfere with study procedures
  • Any of the following deformities of the external ear and tympanic membrane: congenital canal stenosis or atresia, severe canal tortuosity or curvature which prevents visualizing the tympanic membrane fully with an otoscope, canal wall exostoses or osteomas, markedly thickened or opaque tympanic membranes such as caused by chronic myringitis, or scarring or fibrosis of the tympanic membrane, tympanosclerosis or other heavy calcification of the tympanic membrane, tympanic membrane perforations, and grafted tympanic membranes.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Investigational cohort
Pediatric patients 6 months to 18 years who have been scheduled for tympanostomy and ear tube placement.
Device: Laser otoscope examination
Patients will have short videos taken of their tympanic membranes under white light and laser illumination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The primary endpoint is the accuracy, PPV, and NPV of the MEEscope in detecting MEE validated by myringotomy findings. These values will be compared to the standard white-light otoscopy findings in the same patients to demonstrate the relative accuracy of the experimental illumination vs white light illumination in detection of MEE.
From enrollment to data collection at tympanostomy typically at 2-3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MSTATT LLC

Collaborators

The Cleveland Clinic
National Institute on Deafness and Other Communication Disorders (NIDCD)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

March 2, 2026

First Submitted That Met QC Criteria

March 2, 2026

First Posted (Actual)

March 6, 2026

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R43DC022815-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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