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Coherent Optical Detection of Middle Ear Disease
NCT05353569 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DIAGNOSTIC_TEST OCT Device(s)
Study Locations (2)
Wisconsin
- Children's Wisconsin ENT Clinic — Wauwatosa
- Children's Wisconsin Urgent Care Clinics — Wauwatosa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 235 participants |
| Start Date | 2022-05-24 |
| Est. Completion | 2028-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05353569
The ClinicalTrials.gov registry entry for NCT05353569 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 235 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical College of Wisconsin, which has 614 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Otitis Media appearing as the primary indexed condition, and to 1 intervention — of which OCT Device(s) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05353569 reports 2 study locations spanning 1 distinct geographic area — top geographies include Wisconsin. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05353569 about?
NCT05353569 is a clinical study titled "Coherent Optical Detection of Middle Ear Disease". 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 compar...
What is the current status of trial NCT05353569?
This trial is currently recruiting. It is a NA study. The enrollment target is 235 participants. The study started on 2022-05-24. Estimated completion is 2028-04.
What conditions does trial NCT05353569 study?
This clinical trial studies the following conditions: Otitis Media, Otitis Media With Effusion, Otitis Media Acute. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05353569?
The interventions under investigation include: OCT Device(s) (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05353569?
This trial is sponsored by Medical College of Wisconsin, which has 614 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05353569 being conducted?
This trial has 2 study locations across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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