Middle Ear DiseaseNCT05085379
Optical Coherence Tomography of the Middle Ear Using Ossiview
An observational study of Middle Ear Disease, run by University of Arkansas at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Middle Ear Disease
- What is being tested?
- Ossiview
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2023to 2 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Narrow or stenotic external meatus (ear canal)
- Movement disorder causing inability to keep head still during imaging
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, AR, Arkansas, 72205
About this study
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.
- Conditions
- Middle Ear Disease
- Being tested
- Ossiview
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OssiviewDevice
Imaging of the ear using Optical Coherence Tomography
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic correlation with microscopic otoscopy
Comparison of Diagnostic ability to other standard of care (SoC) testing - microscopic otoscopy
Measured: 6 months
Diagnostic correlation with CT scans
Comparison of Diagnostic ability to other standard of care (SoC) testing - CT scans
Measured: 6 months
Diagnostic correlation with Magnetic Resonance Imaging (MRI)s
Comparison of Diagnostic ability to other standard of care (SoC) testing - MRIs
Measured: 6 months
Diagnostic correlation with audiologic testing results
Comparison of Diagnostic ability to other standard of care (SoC) testing - audiologic testing results
Measured: 6 months
Diagnostic correlation with surgical reports
Comparison of Diagnostic ability to other standard of care (SoC) testing - surgical reports
Measured: 6 months
Diagnostic correlation with pathology reports
Comparison of Diagnostic ability to other standard of care (SoC) testing - pathology reports
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start2 Nov 2023
- Primary completion2 Nov 2023
- Study completion2 Nov 2023
Why it stopped: No Subjects enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Middle Ear DiseaseStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deanne King, MD, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085379
- Sponsor's protocol ID
- 262886.
- Status last verified
- Mar 2023
- First submitted
- 7 Oct 2021
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography of the Middle Ear Using Ossiview
- ClinicalTrials.gov ID
- NCT05085379
- Acronym / sponsor ID
- 262886.
- Conditions
- Middle Ear Disease
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No Subjects enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 2 Nov 2023 (actual)
- Study completion
- 2 Nov 2023 (actual)
- First posted
- 20 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Narrow or stenotic external meatus (ear canal)
- Movement disorder causing inability to keep head still during imaging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OssiviewImaging of the ear using Optical Coherence Tomography | Device | – |
Primary outcome
Diagnostic correlation with microscopic otoscopy
Time frame: 6 months
Comparison of Diagnostic ability to other standard of care (SoC) testing - microscopic otoscopy
Diagnostic correlation with CT scans
Time frame: 6 months
Comparison of Diagnostic ability to other standard of care (SoC) testing - CT scans
Diagnostic correlation with Magnetic Resonance Imaging (MRI)s
Time frame: 6 months
Comparison of Diagnostic ability to other standard of care (SoC) testing - MRIs
Diagnostic correlation with audiologic testing results
Time frame: 6 months
Comparison of Diagnostic ability to other standard of care (SoC) testing - audiologic testing results
Diagnostic correlation with surgical reports
Time frame: 6 months
Comparison of Diagnostic ability to other standard of care (SoC) testing - surgical reports
Diagnostic correlation with pathology reports
Time frame: 6 months
Comparison of Diagnostic ability to other standard of care (SoC) testing - pathology reports
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deanne King, MD, PhD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Middle Ear Disease, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic correlation with microscopic otoscopy (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.