| NCT ID | NCT06944795 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stanford University |
| Condition | Otitis Media |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-04-30 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2026-04-30 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Tulio Valdez, MD, MSc
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT06944795 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 17 Years, studying Otitis Media. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06944795 currently recruiting?
Yes, NCT06944795 is actively recruiting participants. Visit ClinicalTrials.gov or contact Stanford University to inquire about joining.
Where is the NCT06944795 trial being conducted?
This trial is being conducted at Palo Alto, United States.
Who is sponsoring the NCT06944795 clinical trial?
NCT06944795 is sponsored by Stanford University. The principal investigator is Tulio Valdez, MD, MSc at Stanford University. The trial plans to enroll 100 participants.