Status:
TERMINATED
Percutaneous Cochlear Implantation: Implementation of Technique
Lead Sponsor:
Vanderbilt University
Conditions:
Hearing Loss
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The investigators are studying a new way of doing cochlear implant surgery called "Percutaneous Cochlear Implantation". In this surgery, instead of doing a mastoidectomy where about 30ml of bone is re...
Eligibility Criteria
Inclusion
- 18-80 year old patients undergoing cochlear implantation who are able to participate in the informed consent process.
- Pre-operative CT scan of head performed as standard of care for cochlear implant work-up.
Exclusion
- Patients with co-morbidities so severe that the potential additional operating room time is deemed to be too significant of an operative risk. This assessment is made by the local institutions pre-operative work-up.
- History of allergic reaction/intolerance of local anesthesia and/or epinephrine.
- History of allergic reaction to titanium.
- Patients with severe anatomical abnormality of the temporal bone.
- Patients with severe chronic ear disease for whom traditional mastoidectomy might offer benefit.
- Females who are pregnant.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01460823
Start Date
October 1 2011
End Date
July 1 2014
Last Update
December 16 2014
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232