SWIR Otoscope: Testing a New Way to See Ear Infections in Kids
Official title: A Short Wave Infrared Otoscope for Objective Middle Ear Effusion Diagnosis
Run by Stanford University · NCT06944795 · Data updated 2026-11-12
This study tests whether a short wave infrared (SWIR) otoscope can better identify middle ear fluid in children undergoing tympanostomy tube placement than a standard white light otoscope.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Year to 17 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Palo Alto, California) |
| Status | Recruiting |
| Started | April 30, 2026 |
| Main results expected | April 30, 2027 |
| Study ends | July 2027 |
| Registry record updated | July 24, 2026 |
| Trial ID | NCT06944795 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 1–17 undergoing tympanostomy tube placement at Stanford, whose guardians provide informed consent/assent.
✕Probably not a fit
Some participants may not experience a diagnostic benefit if SWIR findings do not differ from standard white light results.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study compares a SWIR-enabled otoscope to the standard white light otoscope for diagnosing otitis media in pediatric patients. Participants are children aged 1 to 17 who are undergoing tympanostomy tube placement at Lucile Packard Children’s Hospital and consent to imaging with both devices during the procedure. SWIR and white light data are collected simultaneously to determine the presence or absence of middle ear fluid, using the SWIR results to help validate a more objective diagnostic approach. The study aims to generate preliminary data to support future research on SWIR-based diagnosis and its potential to improve clinical decision-making. The investigation is led by Stanford University with collaboration from NIDCD and is conducted in the operating room setting as part of standard care when fluid is removed.
Why it matters
Potential benefit: If successful, the SWIR otoscope could provide a more accurate and objective diagnosis of middle ear infections, potentially reducing misdiagnosis and unnecessary antibiotic use.
How similar studies have gone: Prior work has shown promise for SWIR-based detection of middle ear effusions, but this study contributes preliminary clinical data in a pediatric surgical setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Stanford University
Palo Alto, California, United States Recruiting
Study contacts
- Principal investigator: Tulio Valdez, MD, MSc — Stanford University
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.