Optical Coherence Tomography of the Middle Ear Using Ossiview
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- University of Arkansas
- Primary Endpoint
- Diagnostic correlation with microscopic otoscopy
Study Overview
Brief Summary
The aim of this study is to understand the diagnostic applications for this imaging technology and identify particular disorders to target for future clinical investigations. Images obtained with the Ossiview device will be correlated to other standard of care (SoC) testing including microscopic otoscopy, CT scans, MRIs, audiologic testing results, and surgical and pathology reports.
Detailed Description
Optical Coherence Tomography (OCT) is an optical imaging technique that uses a low-coherence interferometer to produce depth-resolved scans in tissue. This study will explore the utility of this technology in otology patients presenting with various pathologies as well as normal subjects.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Diagnostic correlation with microscopic otoscopy
Time Frame: 6 months
Comparison of Diagnostic ability to other standard of care (SoC) testing - microscopic otoscopy
Diagnostic correlation with audiologic testing results
Time Frame: 6 months
Comparison of Diagnostic ability to other standard of care (SoC) testing - audiologic testing results
Diagnostic correlation with pathology reports
Time Frame: 6 months
Comparison of Diagnostic ability to other standard of care (SoC) testing - pathology reports
Diagnostic correlation with CT scans
Time Frame: 6 months
Comparison of Diagnostic ability to other standard of care (SoC) testing - CT scans
Diagnostic correlation with surgical reports
Time Frame: 6 months
Comparison of Diagnostic ability to other standard of care (SoC) testing - surgical reports
Diagnostic correlation with Magnetic Resonance Imaging (MRI)s
Time Frame: 6 months
Comparison of Diagnostic ability to other standard of care (SoC) testing - MRIs
Secondary Outcomes
No secondary outcomes reported