Percutaneous Cochlear Implantation: Implementation of Technique

Hearing Loss Clinical Trial

— PCI-I  

Official title:

Percutaneous Cochlear Implantation: Implementation of Technique

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01460823
• Other study ID #: 111114
• Status: Terminated
• Phase: N/A
• First received: October 24, 2011
• Last updated: December 15, 2014
• Start date: October 2011
• Est. completion date: July 2014

Study information

• Verified date: December 2014
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: July 2014
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

Procedure:
• Percutaneous Cochlear Implantation using image guided surgical techniques
Percutaneous Cochlear Implantation using image guided surgical techniques.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes

External Links

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