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Percutaneous Cochlear Implantation: Implementation of Technique

NCT ID: NCT01460823

Last Updated: 2014-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-07-31

Brief Summary

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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

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Conditions

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Hearing Loss

Keywords

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Hearing loss Cochlear Implantation Image guided surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Use of image guided surgery

Group Type EXPERIMENTAL

Percutaneous Cochlear Implantation using image guided surgical techniques

Intervention Type PROCEDURE

Percutaneous Cochlear Implantation using image guided surgical techniques.

Interventions

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Percutaneous Cochlear Implantation using image guided surgical techniques

Percutaneous Cochlear Implantation using image guided surgical techniques.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Robert F. Labadie

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert F. Labadie, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Related Links

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http://www.vanderbilt.edu/CAOS/

Click here for more information related to Dr. Labadie and Otology Research at Vanderbilt University Medical Center

Other Identifiers

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111114

Identifier Type: -

Identifier Source: org_study_id