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WithdrawnNCT05085379Updated Sep 3, 2024

Optical Coherence Tomography of the Middle Ear Using Ossiview

An observational study in Middle Ear Disease, sponsored by University of Arkansas. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-03.

Sponsored by University of Arkansas · Observational

Why this study was withdrawn
No Subjects enrolled
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
0
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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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Conditions studied

  • Middle Ear Disease

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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

Exclusion Criteria

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

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
0 participants (actual)
Patient registry
No

Interventions

  • DeviceOssiview

    Imaging of the ear using Optical Coherence Tomography

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What researchers measure

Primary outcomes

  1. Diagnostic correlation with microscopic otoscopy

    Comparison of Diagnostic ability to other standard of care (SoC) testing - microscopic otoscopy

    Time frame: 6 months

  2. Diagnostic correlation with CT scans

    Comparison of Diagnostic ability to other standard of care (SoC) testing - CT scans

    Time frame: 6 months

  3. Diagnostic correlation with Magnetic Resonance Imaging (MRI)s

    Comparison of Diagnostic ability to other standard of care (SoC) testing - MRIs

    Time frame: 6 months

  4. Diagnostic correlation with audiologic testing results

    Comparison of Diagnostic ability to other standard of care (SoC) testing - audiologic testing results

    Time frame: 6 months

  5. Diagnostic correlation with surgical reports

    Comparison of Diagnostic ability to other standard of care (SoC) testing - surgical reports

    Time frame: 6 months

  6. Diagnostic correlation with pathology reports

    Comparison of Diagnostic ability to other standard of care (SoC) testing - pathology reports

    Time frame: 6 months

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Study locations

1 site
  • University of Arkansas for Medical Sciences
    Little Rock, AR, Arkansas 72205, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT05085379
Lead sponsor
University of Arkansas
Responsible party
Sponsor
First posted
Oct 20, 2021
Start date
Nov 2, 2023
Primary completion
Nov 2, 2023
Completion
Nov 2, 2023
Last update
Sep 3, 2024

Study contacts

Deanne King, MD, PhD
principal investigator · University of Arkansas

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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