A Short Wave Infrared Otoscope for Objective Middle Ear Effusion Diagnosis
Stanford University
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.
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 me…
Eligibility
- Age range
- 1–17 years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- DeviceSWIR device
A Short Wave Infrared (SWIR) Otoscope will record images for both the SWIR and white light video otoscopes. These images of the middle ear will be recorded in AVI format.
Locations (2)
- Stanford UniversityPalo Alto, California
- Children's National HospitalWashington D.C., District of Columbia