Clinical Trials Directory

Trials / Terminated

TerminatedNCT01460823

Percutaneous Cochlear Implantation: Implementation of Technique

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
5 (actual)
Sponsor
Vanderbilt University · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREPercutaneous Cochlear Implantation using image guided surgical techniquesPercutaneous Cochlear Implantation using image guided surgical techniques.

Timeline

Start date
2011-10-01
Primary completion
2012-10-01
Completion
2014-07-01
First posted
2011-10-27
Last updated
2014-12-16

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01460823. Inclusion in this directory is not an endorsement.