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CT Scalar Localization

Sponsor
Mayo Clinic (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04430140
Collaborator
(none)
40
Enrollment
1
Location
23.8
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: CT Scan

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

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
CT Scalar Localization of the Electrode Array Following Cochlear Implantation
Actual Study Start Date :
Dec 8, 2020
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
1

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

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

Outcome Measures

Primary Outcome Measures

  1. Implant Location [3 Years]

    Determining location of implant using CT scan and correlating retained hearing levels

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: John Lane, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
John Lane, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT04430140
Other Study ID Numbers:
  • 19-005543
First Posted:
Jun 12, 2020
Last Update Posted:
Dec 15, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Dec 15, 2021