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Percutaneous Cochlear Implantation: Implementation of Technique (PCI-I)

Primary Purpose

Hearing Loss

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Percutaneous Cochlear Implantation using image guided surgical techniques
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss focused on measuring Hearing loss, Cochlear Implantation, Image guided surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Use of image guided surgery

Arm Description

Outcomes

Primary Outcome Measures

Percentage of participants who underwent successful Cochlear Implantation Via Percutaneous Method
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.

Secondary Outcome Measures

Full Information

First Posted
October 24, 2011
Last Updated
December 15, 2014
Sponsor
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT01460823
Brief Title
Percutaneous Cochlear Implantation: Implementation of Technique
Acronym
PCI-I
Official Title
Percutaneous Cochlear Implantation: Implementation of Technique
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Terminated
Why Stopped
Currently in the process of submitting IDE to the FDA
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
Hearing loss, Cochlear Implantation, Image guided surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Use of image guided surgery
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Cochlear Implantation using image guided surgical techniques
Intervention Description
Percutaneous Cochlear Implantation using image guided surgical techniques.
Primary Outcome Measure Information:
Title
Percentage of participants who underwent successful Cochlear Implantation Via Percutaneous Method
Description
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.
Time Frame
Participants will be followed post operatively until their 1st follow up visit with surgeon which on average is 3 weeks after surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert F. Labadie, MD, PhD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.vanderbilt.edu/CAOS/
Description
Click here for more information related to Dr. Labadie and Otology Research at Vanderbilt University Medical Center

Learn more about this trial

Percutaneous Cochlear Implantation: Implementation of Technique

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