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Evaluating Laser Otoscope for Middle Ear Effusion Detection

NCT07454512 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2026-03-06

No results posted yet for this study

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

  • Middle Ear Effusion
  • Otitis Media

Interventions

DEVICE

Laser otoscope examination

Patients will have short videos taken of their tympanic membranes under white light and laser illumination.

Sponsors & Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

    collaborator NIH

  • The Cleveland Clinic

    collaborator OTHER

  • MSTATT LLC

    lead INDUSTRY

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2026-07-01
Completion
2026-09-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07454512 on ClinicalTrials.gov