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Recruiting NCT05353569

NCT05353569 Coherent Optical Detection of Middle Ear Disease

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Clinical Trial Summary
NCT ID NCT05353569
Status Recruiting
Phase
Sponsor Medical College of Wisconsin
Condition Otitis Media
Study Type INTERVENTIONAL
Enrollment 235 participants
Start Date 2022-05-24
Primary Completion 2027-04

Eligibility & Interventions

Sex All sexes
Min Age 12 Months
Max Age 6 Years
Study Type INTERVENTIONAL
Interventions
OCT Device(s)

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 235 participants in total. It began in 2022-05-24 with a primary completion date of 2027-04.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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.

Eligibility Criteria

Inclusion Criteria: * Parental complaint of ear infection or ear pain (Children's Wisconsin Urgent Care Clinics) OR referred for evaluation of otitis media with effusion (Children's Wisconsin ENT Clinic) * Speak English Exclusion Criteria: * Children with craniofacial abnormalities * Children with diagnosed immunologic abnormalities * Children with congenital syndromic conditions * Current open and functioning ear tubes

Contact & Investigator

Central Contact

Roxanne Link, APNP

✉ rlink@mcw.edu

📞 414-266-3760

Principal Investigator

Joseph Kerschner, MD

PRINCIPAL INVESTIGATOR

Medical College of Wisconsin

Frequently Asked Questions

Who can join the NCT05353569 clinical trial?

This trial is open to participants of all sexes, aged 12 Months or older, up to 6 Years, studying Otitis Media. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT05353569 currently recruiting?

Yes, NCT05353569 is actively recruiting participants. Contact the research team at rlink@mcw.edu for enrollment information.

Where is the NCT05353569 trial being conducted?

This trial is being conducted at Wauwatosa, United States, Wauwatosa, United States.

Who is sponsoring the NCT05353569 clinical trial?

NCT05353569 is sponsored by Medical College of Wisconsin. The principal investigator is Joseph Kerschner, MD at Medical College of Wisconsin. The trial plans to enroll 235 participants.

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