Coherent Optical Detection of Middle Ear Disease

Part of paid clinical trials in Wauwatosa, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT05353569
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
12 Months - 6 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 24, 2022
Status verified
Jan 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
235 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Children's Wisconsin Urgent Care Clinics
    Subjects will receive a standard-of-care otoscopy examination, followed by a research-only examination using an OCT device (PCT).
  • No Intervention: Children's Wisconsin (Effusion in 0 or 1 ear)
    Subjects will only receive a standard-of-care otoscopy examination.
  • Experimental: Children's Wisconsin (Effusion in 2 ears)
    Subjects will receive standard-of-care ear and hearing examinations (otoscopy and audiometry/tympanometry), followed by research-only examinations using two OCT devices (UIUC OCT and PCT).

Primary Outcome Measure

Children's Wisconsin Urgent Care Clinic Analysis (Standard-of-Care Diagnosis) [ Time Frame: 5 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Children's Wisconsin ENT ClinicWauwatosaWisconsin53226
Katherine Peterson, MPH
[email protected]
4148055356
Children's Wisconsin Urgent Care ClinicsWauwatosaWisconsin53226
Katherine Peterson, MPH
[email protected]
4148055356

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Children's Wisconsin ENT Clinic· Wauwatosa, WIChildren's Wisconsin Urgent Care Clinics· Wauwatosa, WI

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