CT Scalar Localization

NCT ID: NCT04430140

Last Updated: 2023-01-06

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WITHDRAWN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

2020-12-31

Study Completion Date

2022-12-31

Brief Summary

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Comparing the location of cochlear implants to level of retained hearing.

Detailed Description

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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

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Cochlear Implant

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

CT Scan

Number of research exams: 1 Effective Dose (mSv) for 1 exam: 0.6 Total Effective Dose (mSv)\*: 0.6

CT Scan

Intervention Type DEVICE

CT Scan

Number of research exams: 1 Effective Dose (mSv) for 1 exam: 0.6 Total Effective Dose (mSv)\*: 0.6

Interventions

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CT Scan

CT Scan

Number of research exams: 1 Effective Dose (mSv) for 1 exam: 0.6 Total Effective Dose (mSv)\*: 0.6

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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John Lane

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John Lane, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Related Links

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Other Identifiers

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19-005543

Identifier Type: -

Identifier Source: org_study_id

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