Cochlear ImplantNCT04430140
CT Scalar Localization
An observational study of Cochlear Implant, run by Mayo Clinic.
Trial summary
Comparing the location of cochlear implants to level of retained hearing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cochlear Implant
- What is being tested?
- CT Scan
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Dec 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Mayo Clinic Patients
Who may be able to join
- Currently scheduled for a cochlear implant or currently have a cochlear implant
- 18 years of age and over
- Male and female
- Capacity to consent for patients will be determined by review of the medical history of subject at screening and in concert with the referring physician. Consent will be signed after all questions have been answered and the participant indicates they understand
Who cannot join
- Younger than 18 years of age
- Current criteria for cochlear implantation
- Currently pregnant, all females will be asked to take a urine pregnancy test if of child bearing age, unless you cannot become pregnant
About this study
Official title: CT Scalar Localization of the Electrode Array Following Cochlear Implantation
Comparing the location of cochlear implants to level of retained hearing.
Read the detailed description
Subjects who have undergone cochlear implant surgery will have a CT scan to determine the exact anatomical location of the implant. This location will then be compared with audio testing levels and operative reports to determine any advances in implantation technique that would result in more preserved hearing
- Conditions
- Cochlear Implant
- Being tested
- CT Scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT ScanDevice
CT Scan
Number of research exams: 1 Effective Dose (mSv) for 1 exam: 0.6 Total Effective Dose (mSv)*: 0.6
| Study group | Role | What they receive |
|---|---|---|
| 1 | CT Scan
Number of research exams: 1 Effective Dose (mSv) for 1 exam: 0.6 Total Effective Dose (mSv)*: 0.6 Receives: Device: CT Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Location
Determining location of implant using CT scan and correlating retained hearing levels
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study startDec 2020 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: Alternative study opened with ENT services.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear ImplantStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Lane, Mayo Clinic
- Investigators
- John Lane, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430140
- Sponsor's protocol ID
- 19-005543
- Status last verified
- Jan 2023
- First submitted
- 8 Jun 2020
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT Scalar Localization of the Electrode Array Following Cochlear Implantation
- ClinicalTrials.gov ID
- NCT04430140
- Acronym / sponsor ID
- 19-005543
- Conditions
- Cochlear Implant
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Alternative study opened with ENT services.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 12 Jun 2020 (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.
Comparing the location of cochlear implants to level of retained hearing.
Detailed description
Subjects who have undergone cochlear implant surgery will have a CT scan to determine the exact anatomical location of the implant. This location will then be compared with audio testing levels and operative reports to determine any advances in implantation technique that would result in more preserved hearing
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: CT ScanCT Scan Number of research exams: 1 Effective Dose (mSv) for 1 exam: 0.6 Total Effective Dose (mSv)*: 0.6 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mayo Clinic Patients
Key inclusion criteria (4 listed)
- Currently scheduled for a cochlear implant or currently have a cochlear implant
- 18 years of age and over
- Male and female
- Capacity to consent for patients will be determined by review of the medical history of subject at screening and in concert with the referring physician. Consent will be signed after all questions have been answered and the participant indicates they understand
Key exclusion criteria (3 listed)
- Younger than 18 years of age
- Current criteria for cochlear implantation
- Currently pregnant, all females will be asked to take a urine pregnancy test if of child bearing age, unless you cannot become pregnant
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 |
|---|---|---|
| CT ScanCT Scan Number of research exams: 1 Effective Dose (mSv) for 1 exam: 0.6 Total Effective Dose (mSv)*: 0.6 | Device | 1 |
Primary outcome
Implant Location
Time frame: 3 Years
Determining location of implant using CT scan and correlating retained hearing levels
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 6 Jan 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Cochlear Implant
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Mi2000 TICI - Post-market Implantation Study
Hearing Loss, Binaural, Cochlear Implantation
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Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
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An Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients
Cochlear Implant Recipients, Hearing Loss, Cochlear
Active, not recruiting
An Investigation to Validate Speech Perception Assessment for Adult Cochlear Recipients Using a Mobile Research App
Hearing Loss
Recruiting
Pitch Perception and Memory: Deficits and Training
Cochlear Implants
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.
John Lane, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
An observational study of Cochlear Implant, run by Mayo Clinic.
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 4 inclusion and 3 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 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Implant Location (time frame: 3 Years). 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 6 Jan 2023.