Evaluating Laser Otoscope for Middle Ear Effusion Detection

MSTATT LLC

Status: Not yet enrolling

Conditions: Middle Ear Effusion; Otitis Media

Treatments: Device: Laser otoscope examination

Study type: Observational

Funder types: Other; Industry; NIH

Identifiers

NCT07454512

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

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 6 months to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

150 participants in 1 patient group

Investigational cohort

Description:

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

Treatment:

Device: Laser otoscope examination