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

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ClinicalTrials.gov Identifier: NCT01460823
Recruitment Status : Terminated (Currently in the process of submitting IDE to the FDA)
First Posted : October 27, 2011
Last Update Posted : December 16, 2014
Sponsor:
Information provided by (Responsible Party):
Robert F. Labadie, 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.

Condition or disease Intervention/treatment Phase
Hearing Loss Procedure: Percutaneous Cochlear Implantation using image guided surgical techniques Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Percutaneous Cochlear Implantation: Implementation of Technique
Study Start Date : October 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Use of image guided surgery Procedure: Percutaneous Cochlear Implantation using image guided surgical techniques
Percutaneous Cochlear Implantation using image guided surgical techniques.




Primary Outcome Measures :
  1. Percentage of participants who underwent successful Cochlear Implantation Via 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. ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460823


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Robert F. Labadie, MD, PhD Vanderbilt University Medical Center

Additional Information:
Responsible Party: Robert F. Labadie, Associate Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01460823     History of Changes
Other Study ID Numbers: 111114
First Posted: October 27, 2011    Key Record Dates
Last Update Posted: December 16, 2014
Last Verified: December 2014

Keywords provided by Robert F. Labadie, Vanderbilt University:
Hearing loss
Cochlear Implantation
Image guided surgery

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms