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Clinical Trials/NCT05085379
NCT05085379
Withdrawn
Not Applicable

Optical Coherence Tomography of the Middle Ear Using Ossiview

University of Arkansas0 sitesNovember 2, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Middle Ear Disease
Sponsor
University of Arkansas
Primary Endpoint
Diagnostic correlation with microscopic otoscopy
Status
Withdrawn
Last Updated
2 years ago

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.

Registry
clinicaltrials.gov
Start Date
November 2, 2023
End Date
November 2, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

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