SWIR Otoscopy Study

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT06944795
Status
Not Yet Recruiting

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Conditions

  • Otitis Media
  • Otitis Media Chronic
  • Otitis Media Effusion

Eligibility Criteria

Sex
ALL
Age
1 Year - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • SWIR device — 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.

Study Details

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.

Key Dates

Start date
May 1, 2025
Status verified
Apr 2025
Primary completion
Jun 1, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

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.

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 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94304
Tulio Valdez, MD, MSc (PRINCIPAL_INVESTIGATOR)
Children's National HospitalWashington D.C.District of Columbia20010
Diego Preciado, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Palo Alto, CA

By research site
Stanford University· Palo Alto, CAChildren's National Hospital· Washington D.C., DC

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