A Study to Assess CT Scalar Localization of the Electrode Array Following Cochlear Implantation
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 19-005543
NCT ID: NCT04430140
Sponsor Protocol Number: 19-005543
About this study
The purpose of this study is to correlate scalar localization of the electrode array with intra-operative observations in an effort to advance surgical technique, intra-operative monitoring and device design to improve post-operative hearing outcomes.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator John Lane, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available