Middle Ear Disease Clinical Trial
Official title:
Optical Coherence Tomography of the Middle Ear Using Ossiview
NCT number | NCT05085379 |
Other study ID # | 262886 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | November 2, 2023 |
Est. completion date | November 2, 2023 |
Verified date | March 2023 |
Source | University of Arkansas |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 2, 2023 |
Est. primary completion date | November 2, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria - Age =18 years - Ability to understand the consent process with adequate language and cognitive communication ability - Presence of one of the pathologies (either currently or in the past) above or healthy control Exclusion Criteria - Narrow or stenotic external meatus (ear canal) - Movement disorder causing inability to keep head still during imaging |
Country | Name | City | State |
---|---|---|---|
United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
Lead Sponsor | Collaborator |
---|---|
University of Arkansas |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic correlation with microscopic otoscopy | Comparison of Diagnostic ability to other standard of care (SoC) testing - microscopic otoscopy | 6 months | |
Primary | Diagnostic correlation with CT scans | Comparison of Diagnostic ability to other standard of care (SoC) testing - CT scans | 6 months | |
Primary | Diagnostic correlation with Magnetic Resonance Imaging (MRI)s | Comparison of Diagnostic ability to other standard of care (SoC) testing - MRIs | 6 months | |
Primary | Diagnostic correlation with audiologic testing results | Comparison of Diagnostic ability to other standard of care (SoC) testing - audiologic testing results | 6 months | |
Primary | Diagnostic correlation with surgical reports | Comparison of Diagnostic ability to other standard of care (SoC) testing - surgical reports | 6 months | |
Primary | Diagnostic correlation with pathology reports | Comparison of Diagnostic ability to other standard of care (SoC) testing - pathology reports | 6 months |
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