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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01460823
Other study ID # 111114
Secondary ID
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


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
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