SWIR Otoscopy Study

Stanford University

Status: Not yet enrolling

Conditions: Otitis Media; Otitis Media Effusion; Otitis Media Chronic

Treatments: Device: SWIR device

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06944795

R01DC021326 (U.S. NIH Grant/Contract)

IRB 44549

Details and patient eligibility

About

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.

Full description

Millions of children worldwide obtain an antibiotic prescription for treatment of an ear infection (otitis media), and this has been ranked in the top five conditions for direct medical spending for those under 18 years of age. Otitis media is responsible for the vast majority of tympanostomy tube placements, the most common surgical procedure in the US in children with over 600,000 cases per year. Otitis media is inadequately diagnosed and consequently mistreated. Diagnosis is estimated at 51% for US pediatricians, with over-diagnosis occurring 26% of the time. Accurate diagnosis of otitis media can be an issue as it requires a physician to differentiate between various forms of middle ear conditions. The standard of care (SOC) for diagnosing otitis media is pneumotoscopy by eye or using a white light video otoscope. This technique has advantages, but it suffers from subjective interpretations, especially in the hands of inexperienced practitioners. Our team developed the first otoscope sensitive to short wave infrared (SWIR) light for objective identification of middle ear effusions. The SWIR otoscope collects both the information normally seen by a white light otoscope, and SWIR light. The goal with this research is to evaluate the SWIR otoscope against the white light otoscope currently used as the standard of care diagnostic tool in clinic settings. Patients who are undergoing a tympanostomy tube placement procedure will be eligible for this study. In the operating room, imaging will be performed with the SWIR otoscope, which will gather images of both SWIR data and white light data simultaneously. As part of SOC, patients who come into the operating room for the procedure will have removal of middle ear fluid as part of the procedure. The physician performing the procedure will take note of the presence or absence of middle ear fluid. A different physician and a computer program will analyze the images of the SWIR otoscope for presence or absence of middle ear fluid in the image. These results will be compared with the notes taken during the procedure regarding presence or absence of ear fluid.

Enrollment: 100 estimated patients

Sex: All

Ages: 1 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Patients under 1 year of age or 18 and older
• Participants not meeting the inclusion criteria

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

SWIR otoscope + white light otoscope

Experimental group

Description:

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.

Treatment:

Device: SWIR device