MedTrace Logo

Coherent Optical Detection of Middle Ear Disease

NCT05353569 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 235

Last updated 2026-01-21

No results posted yet for this study

Summary

The purpose of this project is to see if optical coherence tomography (OCT), a new technology acting as an ultrasound for the ear, facilitates accurately diagnosing acute otitis media (AOM) and otitis media with effusion (OME) in children. Clinical diagnoses made using solely otoscopy will be compared to those made with the addition of OCT.

Conditions

  • Otitis Media
  • Otitis Media With Effusion
  • Otitis Media Acute

Interventions

DIAGNOSTIC_TEST

OCT Device(s)

Results from standard-of-care examinations will be compared to research-only examination(s) (OCT device(s)).

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

  • University of Illinois at Urbana-Champaign

    collaborator OTHER

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

    collaborator NIH

Principal Investigators

  • Joseph Kerschner, MD · Medical College of Wisconsin

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-24
Primary Completion
2027-04-30
Completion
2028-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05353569 on ClinicalTrials.gov