NCT04430140

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2020

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 12, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 6, 2023

Status Verified

January 1, 2023

Enrollment Period

2 years

First QC Date

June 8, 2020

Last Update Submit

January 4, 2023

Conditions

Cochlear Implant

Outcome Measures

Primary Outcomes (1)

  • Implant Location

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

    3 Years

Study Arms (1)

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

Interventions

CT ScanDEVICE

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

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Mayo Clinic Patients

You may qualify if:

  • Currently scheduled for a cochlear implant or currently have a cochlear implant
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Interventions

Tomography, X-Ray Computed

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomography

Study Officials

  • John Lane, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 8, 2020

First Posted

June 12, 2020

Study Start

December 1, 2020

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

January 6, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share