SWIR Otoscopy Study
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
SWIR device
DeviceA 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: SWIR otoscope + white light otoscopeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of accurate diagnoses made by SWIR otoscope as confirmed by presence/absence of fluid during tympanostomy tube placement
Patients who are having a tympanostomy tube placement procedure at the LPCH will undergo removal of middle ear fluid as part of their standard of care. During the procedure, the physician will use the SWIR otoscope to take images using the SWIR and the white light otoscope. The physician conducting the procedure will take note of whether there was a presence of absence of middle ear fluid. A different physician and a computer program. The accuracy of the otscopes will be determined by comparing the physician and program's diagnoses to physical presence of fluid when the ear is drained during the tympanostomy tube placement.
Time frame
30 minutesSponsors and contacts
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Stanford University
Lead sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
Source ClinicalTrials.gov