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Image of Midtown Health Center (Children's Wisconsin) in Milwaukee, United States.

Diagnostic Test

OCT Device for Ear Infection (OCTII Trial)

Wauwatosa, WI

N/A

Recruiting

Led By Joseph Kerschner, MD

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Must not have

Children with craniofacial abnormalities

Children with diagnosed immunologic abnormalities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new technology to see if it helps doctors better diagnose two types of ear infections in children.

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Who is the study for?

This trial is for children with a parent-reported ear infection or pain, or those referred for otitis media with effusion evaluation at specific clinics. Participants must speak English. Children with current ear tubes, craniofacial abnormalities, immunologic or syndromic conditions, or effusion present for less than 8 weeks are excluded.Check my eligibility

What is being tested?

The study tests if optical coherence tomography (OCT), like an ultrasound for the ear, can accurately diagnose acute otitis media and otitis media with effusion in kids. It compares clinical diagnoses using OCT alongside traditional pneumatic otoscopy to those using only pneumatic otoscopy.See study design

What are the potential side effects?

Since OCT is a non-invasive imaging test similar to taking a photograph of the inside of the ear, it does not have side effects like medications do. However, there may be minimal discomfort from placing the device near the child's ear.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My child has a craniofacial abnormality.

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My child has a diagnosed immune system disorder.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Children's Wisconsin ENT Clinic Analysis (Research Devices Diagnosis)

Children's Wisconsin ENT Clinic Analysis (Standard-of-Care Diagnosis)

Children's Wisconsin Urgent Care Analysis (Research Device Diagnosis)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Children's Wisconsin Urgent Care ClinicsExperimental Treatment1 Intervention

Subjects will receive a standard-of-care otoscopy examination, followed by a research-only examination using an OCT device (PCT).

Group II: Children's Wisconsin (Effusion in 2 ears)Experimental Treatment1 Intervention

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).

Group III: Children's Wisconsin (Effusion in 0 or 1 ear)Active Control1 Intervention

Subjects will only receive a standard-of-care otoscopy examination.

0 / 2Eligibility criteria met