Percutaneous Cochlear Implantation: Implementation of Technique

NCT01460823 | Terminated DMC

• 1 other identifier: 111114
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss

Keywords

Hearing loss; Cochlear Implantation; Image guided surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  Participants will be followed post operatively until their 1st follow up visit with surgeon which on average is 3 weeks after surgery.

Study Arms (1)

Use of image guided surgery

EXPERIMENTAL

Procedure: Percutaneous Cochlear Implantation using image guided surgical techniques

Interventions

Percutaneous Cochlear Implantation using image guided surgical techniques PROCEDURE

Percutaneous Cochlear Implantation using image guided surgical techniques.

Use of image guided surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Links

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

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert F. Labadie, MD, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 24, 2011
• First Posted: October 27, 2011
• Study Start: October 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: July 1, 2014
• Last Updated: December 16, 2014

Record last verified: 2014-12

Locations

US (1)