Percutaneous Cochlear Implantation: Implementation of Technique
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Percentage of participants who underwent successful Cochlear Implantation Via Percutaneous Method
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Percentage of participants who underwent successful Cochlear Implantation Via Percutaneous Method
时间窗: 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.
次要结局
未报告次要终点
研究者
Robert F. Labadie
Associate Professor
Vanderbilt University