Myringotomy Clinical Trials

Clinical trials related to Myringotomy Procedure

A Short Wave Infrared Otoscope for Objective Middle Ear Effusion Diagnosis

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The aim of this study is to provide preliminary data to support future studies to demonstrate that the short wave infrared (SWIR) otoscope is a better diagnostic tool than a white light otoscope for diagnosing middle ear infections (otitis media). Patients who are having a tympanostomy tube placement procedure will be participating in this study. Imaging will be performed with the white light otoscope and the SWIR otoscope to determine presence of absence of fluid. The SWIR otoscope will gather SWIR data and white light data simultaneously. As part of standard of care, patients who come in for this procedure have removal of middle ear fluid as part of their procedure, which will confirm presence or absence of fluid.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 17
Healthy Volunteers: f
View:

• Ages 1-17

• Being seen in the Ear, Nose, and Throat Clinic at Lucile Packard Childrens Hospital

• Undergoing tympanostomy tube placement as part of standard of care

• Parents and/or patient has the ability to understand and the willingness to sign a written informed consent form or assent form.

Locations
United States
California
Stanford University
RECRUITING
Palo Alto
Time Frame
Start Date: 2026-04-30
Estimated Completion Date: 2027-07
Participants
Target number of participants: 100
Treatments
Experimental: SWIR otoscope + white light otoscope
Patients who are undergoing a tympanostomy tube placement as part of standard of care will have their middle ears imaged with the SWIR otoscope. The SWIR otoscope will record images/recordings of the SWIR otoscope and the white light otoscope, therefore, there will only be one arm of the study because all patients will be imaged with the white light and the SWIR.
Sponsors
Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
Leads: Stanford University

This content was sourced from clinicaltrials.gov