Clinical Trials Logo
  1. Home
  2. Cochlear Implant
  3. NCT04430140
  4. Details
NCT04430140 Clinical Trial

CT Scalar Localization

Cochlear Implant Clinical Trial

Official title:
CT Scalar Localization of the Electrode Array Following Cochlear Implantation

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04430140
Other study ID # 19-005543
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date December 2020
Est. completion date December 2022

Study information
Verified date January 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Outcome
Type Measure Description Time frame Safety issue
Primary Implant Location Determining location of implant using CT scan and correlating retained hearing levels 3 Years
See also
  Status Clinical Trial Phase
Completed NCT04222296 - Bimodal, CROS and Severe Profound Hearing Loss Study N/A
Completed NCT04577118 - The iotaSOFT Insertion System Safety Study N/A
Withdrawn NCT04041596 - Degree of Benefit From Low-Frequency Acoustic Amplification Using the Advanced Bionics Acoustic Earhook Phase 4
Completed NCT01737489 - Title: "Development and Implementation of Innovative Auditory Training Methods and Verification of These Training Methods" N/A
Completed NCT03304106 - Clinical Investigation of New CI Delivery Models in an Adult Nucleus CI Population N/A
Active, not recruiting NCT03685461 - AB-Intra- and Post-Operative Measures of Auditory Function N/A
Completed NCT03515473 - Subjective and Objective Results With CI Electrode Types
Terminated NCT03025386 - Establish a Concordance Between the Mismatch Negativity Amplitude and a Score of Logatoms Discrimination N/A
Completed NCT02966379 - Hearing Preservation and Electro-acoustic Stimulation With EVO® Electrode Lead and Zebra® Sound Processor N/A
Not yet recruiting NCT05275712 - Outcome of Cochlear Implant in Assiut University
Completed NCT03202797 - Optimizing Regulation of a Cochlear Implant in Patients With Functional Contralateral Audition.
Recruiting NCT05360212 - Anatomy-based Fitting in Cochear Implant Users N/A
Not yet recruiting NCT06142682 - Dexamethasone Eluting Cochlear Implant: a Pivotal Study N/A
Recruiting NCT03886168 - Pediatric Image-Guided Cochlear Implant Programming N/A
Enrolling by invitation NCT03306082 - Image-guided Cochlear Implant Programming (IGCIP) N/A
Enrolling by invitation NCT04320251 - Tissue Growth Characterization for Cochlear Implant Users N/A
Recruiting NCT05079867 - Cochlear Trauma, Functional and Structural Preservation in Cochlear Implant Surgery
Recruiting NCT06086041 - Predictive Study on Hearing Rehabilitation After Cochlear Implant
Active, not recruiting NCT04722042 - Place-based Mapping in EAS Listeners N/A
Recruiting NCT04711538 - Role of Diagnostic Imaging in Cochlear Implant

External Links