Recruiting

SWIR Otoscope

Sponsor:

Stanford University

Code:

NCT06944795

Conditions

Otitis Media

Otitis Media Chronic

Otitis Media Effusion

Eligibility Criteria

Sex: All

Age: 1 - 17

Healthy Volunteers: Not accepted

Interventions

SWIR device

Study Details

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.

Conditions

Otitis Media

Otitis Media Chronic

Otitis Media Effusion

Study ID

NCT06944795

Start date

Apr 30, 2026

Status verified date

Jul, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: SWIR otoscope + white light otoscope

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.

Interventions

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.

Primary outcome measure

  • Number of accurate diagnoses made by SWIR otoscope as confirmed by presence/absence of fluid during tympanostomy tube placement [ Time Frame: 30 minutes ]

Central Contacts and Locations

Locations

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Andrea Miranda, MS

6504972402andream7@stanford.edu

Principal Investigator:

Tulio Valdez, MD, MSc

More Information

Sponsor

Stanford University

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Keywords

  • middle ear infections
  • ear infections
  • pediatric ear infections
  • otitis media
  • chronic otitis media
  • chronic otitis media with effusion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-07-24.