Optical Coherence Tomography of the Middle Ear Using Ossiview

Withdrawn

• Conditions: Middle Ear Disease

• Registration Number: NCT05085379
• Lead Sponsor: University of Arkansas

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 Timeline

• Study First Submitted: 2021-10-07
• Study First Submitted QC: 2021-10-07
• Study First Posted: 2021-10-20
• Status Verified: 2023-03
• Study Start: 2023-11-02
• Primary Completion: 2023-11-02
• Study Completion: 2023-11-02
• Last Update Submitted: 2023-11-02
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic correlation with microscopic otoscopy	6 months	Comparison of Diagnostic ability to other standard of care (SoC) testing - microscopic otoscopy
Diagnostic correlation with audiologic testing results	6 months	Comparison of Diagnostic ability to other standard of care (SoC) testing - audiologic testing results
Diagnostic correlation with pathology reports	6 months	Comparison of Diagnostic ability to other standard of care (SoC) testing - pathology reports
Diagnostic correlation with CT scans	6 months	Comparison of Diagnostic ability to other standard of care (SoC) testing - CT scans
Diagnostic correlation with surgical reports	6 months	Comparison of Diagnostic ability to other standard of care (SoC) testing - surgical reports
Diagnostic correlation with Magnetic Resonance Imaging (MRI)s	6 months	Comparison of Diagnostic ability to other standard of care (SoC) testing - MRIs