SWIR Otoscopy Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-17
SponsorStanford University

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

Patients under 1 year of age or 18 and older

Participants not meeting the inclusion criteria

Trial design

Treatments tested in this trial

  • SWIR device

Treatment groups

100 Participants
are divided into 1 treatment group

Sponsors and collaborators

Stanford University

Lead sponsor

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator