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Not yet recruiting NCT07454512

Evaluating Laser Otoscope for Middle Ear Effusion Detection

— Observational Middle Ear Effusion Otitis Media

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Laser otoscope examination.
Who it may be relevant to
Registry conditions: Middle Ear Effusion, Otitis Media. Basic parameters: 6 months — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

United States · 1 center
  • The Cleveland Clinic Foundation — Cleveland

Identifiers

NCT: NCT07454512 · 1R43DC022815-01A1 · 1R43DC022815-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗