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Percutaneous Cochlear Implantation: Implementation of Technique

NCT01460823 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2014-12-16

No results posted yet for this study

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

PROCEDURE

Percutaneous Cochlear Implantation using image guided surgical techniques

Percutaneous Cochlear Implantation using image guided surgical techniques.

Sponsors & Collaborators

  • Vanderbilt University

    lead OTHER

Principal Investigators

  • Robert F. Labadie, MD, PhD · Vanderbilt University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-10-31
Completion
2014-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01460823 on ClinicalTrials.gov