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Diagnostic Test

OCT Device for Ear Infection (OCTII Trial)

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

OCTII Trial Summary

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

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.

OCTII Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

OCTII 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 pneumatic 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 (pneumatic otoscopy and audiology/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 pneumatic otoscopy examination.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH

2,697 Previous Clinical Trials

7,492,362 Total Patients Enrolled

University of Illinois at Urbana-ChampaignOTHER

188 Previous Clinical Trials

37,100 Total Patients Enrolled

Medical College of WisconsinLead Sponsor

609 Previous Clinical Trials

1,162,348 Total Patients Enrolled

Media Library

OCT Device(s) (Diagnostic Test) Clinical Trial Eligibility Overview. Trial Name: NCT05353569 — N/A

Ear Infection Research Study Groups: Children's Wisconsin Urgent Care Clinics, Children's Wisconsin (Effusion in 2 ears), Children's Wisconsin (Effusion in 0 or 1 ear)

Ear Infection Clinical Trial 2023: OCT Device(s) Highlights & Side Effects. Trial Name: NCT05353569 — N/A

OCT Device(s) (Diagnostic Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05353569 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility open to include me in this research endeavor?

"The requirements for admission to this clinical trial are otitis media and an age between 6 Months and 6 years. The maximum number of participants allowed is 235 individuals."

Answered by AI

Does this trial have an age restriction, and if so, what is the upper limit?

"The eligibility criteria for this trial necessitates that participants are between 6 months to 6 years old. There is a total of 19 trials available for minors, and 11 trials accessible to seniors 65 and over."

Answered by AI

How many participants is the maximum capacity for this clinical trial?

"Affirmative. According to the information provided on clinicaltrials.gov, this medical experiment is still open for enrolment; it was first announced on May 24th 2022 and has been revised as recently as September 1st 2022. The researchers require 235 participants from 2 centres in order to complete their study."

Answered by AI

Can any individuals still join this experiment?

"Affirmative. Per the information hosted on clinicaltrials.gov, this medical experiment is actively accruing participants since its initial posting on May 24th 2022 and last edit on September 1st 2022. A total of 235 patients are sought from 2 distinct sites for enrolment in the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Coherent Optical Detection of Middle Ear Disease

Joseph Kerschner 2022. "Coherent Optical Detection of Middle Ear Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05353569.