Optical Coherence Tomography of the Middle Ear Using Ossiview

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.

Study Overview

• Status: Withdrawn
• Conditions: Middle Ear Disease
• Intervention / Treatment: Device: Ossiview

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 Type: Observational

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Target pathologies in the subject population are subjects with:

• Chronic ear disease
• Suspected mixed hearing loss or sensorineural hearing loss
• Otosclerosis
• Suspected or confirmed conductive hearing loss
• Cholesteatoma
• Otitis Media
• Ossicular erosion
• Perforated TM
• Ossicular fixation
• Functioning middle ear prosthesis
• Failed middle ear prosthesis
• Head/Ear trauma patients
• Cochlear implant patients
• Previous tympanoplasty
• Vascular defects
• Tympanosclerosis

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Arkansas
• Investigators: Principal Investigator: Deanne King, MD, PhD, University of Arkansas

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2023
• Primary Completion (Actual): November 2, 2023
• Study Completion (Actual): November 2, 2023

Study Registration Dates

• First Submitted: October 7, 2021
• First Submitted That Met QC Criteria: October 7, 2021
• First Posted (Actual): October 20, 2021

Study Record Updates

• Last Update Posted (Actual): September 3, 2024
• Last Update Submitted That Met QC Criteria: August 29, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases
• Other Study ID Numbers: 262886.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No