Optical Coherence Tomography of the Middle Ear Using Ossiview

NCT ID: NCT05085379

Last Updated: 2024-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-02

Study Completion Date

2023-11-02

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Middle Ear Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Ossiview

Imaging of the ear using Optical Coherence Tomography

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Arkansas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Deanne King, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

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University of Arkansas for Medical Sciences

Little Rock, AR, Arkansas, United States

Site Status

Countries

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United States

Other Identifiers

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262886.

Identifier Type: -

Identifier Source: org_study_id

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