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Optical Coherence Tomography of the Middle Ear Using Ossiview

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ClinicalTrials.gov Identifier: NCT05085379
Recruitment Status : Not yet recruiting
First Posted : October 20, 2021
Last Update Posted : October 20, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Middle Ear Disease 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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Optical Coherence Tomography of the Middle Ear Using Ossiview
Estimated Study Start Date : January 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Disorders


Intervention Details:
  • Device: Ossiview
    Imaging of the ear using Optical Coherence Tomography


Primary Outcome Measures :
  1. Diagnostic correlation with microscopic otoscopy [ Time Frame: 6 months ]
    Comparison of Diagnostic ability to other standard of care (SoC) testing - microscopic otoscopy

  2. Diagnostic correlation with CT scans [ Time Frame: 6 months ]
    Comparison of Diagnostic ability to other standard of care (SoC) testing - CT scans

  3. Diagnostic correlation with Magnetic Resonance Imaging (MRI)s [ Time Frame: 6 months ]
    Comparison of Diagnostic ability to other standard of care (SoC) testing - MRIs

  4. Diagnostic correlation with audiologic testing results [ Time Frame: 6 months ]
    Comparison of Diagnostic ability to other standard of care (SoC) testing - audiologic testing results

  5. Diagnostic correlation with surgical reports [ Time Frame: 6 months ]
    Comparison of Diagnostic ability to other standard of care (SoC) testing - surgical reports

  6. Diagnostic correlation with pathology reports [ Time Frame: 6 months ]
    Comparison of Diagnostic ability to other standard of care (SoC) testing - pathology reports



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05085379


Contacts
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Contact: Deanne King, MD, PhD (501) 686-5427 DKing3@uams.edu

Locations
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United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Contact: Deanne King, MD, PhD    501-686-5427    dking3@uams.edu   
Sub-Investigator: John Dornhoffer, MD, PhD         
Sponsors and Collaborators
University of Arkansas
Investigators
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Principal Investigator: Deanne King, MD, PhD University of Arkansas
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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT05085379    
Other Study ID Numbers: 262886
First Posted: October 20, 2021    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Ear Diseases
Otorhinolaryngologic Diseases