Optical Coherence Tomography of the Middle Ear Using Ossiview

NCT05085379 | Withdrawn DMC FDA Device

• 1 other identifier: 262886.
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Middle Ear Disease

Outcome Measures

Primary Outcomes (6)

• 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

Interventions

Ossiview DEVICE

Imaging of the ear using Optical Coherence Tomography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Narrow or stenotic external meatus (ear canal)
• Movement disorder causing inability to keep head still during imaging

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, AR, Arkansas, 72205, United States

Location

Study Officials

• Deanne King, MD, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 20, 2021
• Study Start: November 2, 2023
• Primary Completion: November 2, 2023
• Study Completion: November 2, 2023
• Last Updated: September 3, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)