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
Sponsors and collaborators
Stanford University
Lead sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator