Optical Coherence Tomography of the Middle Ear Using Ossiview

  • STATUS
    Recruiting
  • End date
    Jul 9, 2024
  • participants needed
    300
  • sponsor
    University of Arkansas
Updated on 9 September 2023
Accepts healthy volunteers

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.

Details
Condition Middle Ear Disease
Treatment Ossiview
Clinical Study IdentifierNCT05085379
SponsorUniversity of Arkansas
Last Modified on9 September 2023

Eligibility

Yes No Not Sure

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
Clear my responses

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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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