SWIR Otoscopy Study

April 25, 2025 updated by: Tulio Valdez, Stanford University

A Short Wave Infrared Otoscope for Objective Middle Ear Effusion Diagnosis

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University
        • Principal Investigator:
          • Tulio Valdez, MD, MSc
    • District of Columbia
      • Washington DC, District of Columbia, United States, 20010
        • Children's National Hospital
        • Principal Investigator:
          • Diego Preciado, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of accurate diagnoses made by SWIR otoscope as confirmed by presence/absence of fluid during tympanostomy tube placement
Time Frame: 30 minutes
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.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: Tulio Valdez, MD, MSc, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

April 18, 2025

First Submitted That Met QC Criteria

April 18, 2025

First Posted (Actual)

April 25, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 25, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 44549
  • R01DC021326 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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