An interventional study of SWIR device in Otitis Media, Otitis Media Chronic and Otitis Media Effusion, sponsored by Stanford University. Recruiting at 1 site in United States. Open to participants aged 1 Year to 17 Years. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by Stanford University · Not applicable, Interventional, and Diagnostic
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.
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.
88 studies on the registry are indexed under Otitis Media with Effusion; 17 are open to participants now.
This study's planned enrollment of 100 is above the median of 80 across 61 interventional studies indexed under Otitis Media with Effusion.
Browse Otitis Media with Effusion studies →Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.
Compared within Otitis Media with Effusion, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Otitis Media. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: SWIR 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.
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 minutes
Plan to share: No
Started Apr 2026 (actual). Primary completion is estimated for Apr 2027, 12 months after the start.
Of 16 interventional studies with no phase under Otitis Media with Effusion, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 65. This study's planned 12 months is below that.
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