Percutaneous Cochlear Implantation: Implementation of Technique
Stopped early · Not applicable
Conditions studied: Hearing Loss
In brief
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 removed, the investigators use image-guided technology (similar to GPS systems used to guide automobile travel) to drill directly from the surface of the skull to the cochlea, removing less than 2ml of bone. To use this technique, three markers (or anchor screws) are screwed into the bone around the ear. Next, an x-ray of the head (called a CT scan) is taken. Using this CT scan, a path to the inner ear (cochlea) is planned and a drill guide (Microtable) is made that mounts on the anchor screws. A drill will be attached to the guide and used to drill a path from the surface of the skull to the inner ear (cochlea). The implant electrode will be threaded through this path. All of these procedures take place under general anesthesia.
Key facts
- Study ID
- NCT01460823
- Run by
- Vanderbilt University
- People needed
- 5
- Starts
- 2011-10-01
- Expected to finish
- 2014-07-01
- Last updated by the study team
- 2014-12-16
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.