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

Vanderbilt University

Status: Terminated

Conditions: Hearing Loss

Treatments: Procedure: Percutaneous Cochlear Implantation using image guided surgical techniques

Study type: Interventional

Funder types: Other

Identifiers

NCT01460823

111114

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Use of image guided surgery

Experimental group

Treatment:

Procedure: Percutaneous Cochlear Implantation using image guided surgical techniques