Evaluating Laser Otoscope for Middle Ear Effusion Detection

NCT07454512 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 1R43DC022815-01A1
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Clinician diagnostic accuracy using laser otoscope to assess middle ear effusion presence

  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

Study Arms (1)

Investigational cohort

Pediatric patients 6 months to 18 years who have been scheduled for tympanostomy and ear tube placement.

Device: Laser otoscope examination

Interventions

Laser otoscope examination DEVICE

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

Investigational cohort

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• MSTATT LLC: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator
• The Cleveland Clinic: collaborator

Study Sites (1)

The Cleveland Clinic Foundation

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Otitis Media with Effusion; Otitis Media

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 6, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

US (1)