Percutaneous Cochlear Implantation: Implementation of Technique

Not Applicable

Terminated

• Conditions: Hearing Loss
• Interventions: Procedure: Percutaneous Cochlear Implantation using image guided surgical techniques

• Registration Number: NCT01460823
• Lead Sponsor: Vanderbilt University

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-24
• Study First Submitted QC: 2011-10-26
• Study First Posted: 2011-10-27
• Primary Completion: 2012-10
• Study Completion: 2014-07
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-15
• Last Update Posted: 2014-12-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Use of image guided surgery	Percutaneous Cochlear Implantation using image guided surgical techniques	-

Primary Outcome Measures

Name	Time	Method
Percentage of participants who underwent successful Cochlear Implantation Via Percutaneous Method	Participants will be followed post operatively until their 1st follow up visit with surgeon which on average is 3 weeks after surgery.	A successful percutaneous cochlear implantation is one where the facial nerve was not damaged during the procedure and the surgeon did not resort back to the standard implantation method. We will measure the percentage of participants who underwent successful cochlear implantation via the percutaneous method.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States