Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

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Status Withdrawn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

Study information

Verified date March 2023
Source University of Arkansas
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Ossiview
Imaging of the ear using Optical Coherence Tomography

Locations

Country Name City State
United States University of Arkansas for Medical Sciences Little Rock Arkansas

Sponsors (1)

Lead Sponsor Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT04776967 - Effect of Total Compression Time and Rate (Slope) on Incidence of Symptomatic ETD and MEB: A Phase II Prospective Study. N/A
Not yet recruiting NCT06434636 - The Effect of Tranexamic Acid in Endoscopic and Microscopic Ear Surgery Cases on Surgeon Satisfaction N/A
Recruiting NCT04804098 - Effect of Rate (Slope) of Compression on the Incidence of Symptomatic ETD and MEB: a Phase III Prospective Study. N/A
Completed NCT01925729 - TransMEM Gas Exchange -- Project 1, Aim 2 Phase 1
Recruiting NCT03297736 - Improved Otologic Implants on Demand Intraoperatively With 3D CAD/CAM Autografts N/A
Recruiting NCT05055115 - Ph.D.-Project: Eustachian Tube Dysfunction: Causes, Diagnosis, Treatment, and Prognosis N/A
Completed NCT05813119 - Efficacy of Digital Otoscope and Otoendoscope for Diagnosis of Middle Ear Pathology