The Performance of a Robot-assisted Minimally Invasive Direct Cochlear Access for Cochlear Implantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Relative ratio of successful electrode array insertions through the drilled direct cochlear access with the HEARO procedure to the total HEARO procedures.
研究概览
简要总结
The cochlear implant is a neural prosthesis and has been the gold standard treatment for severe to profound sensorineural hearing loss over several decades. The surgical procedure for cochlear implantation aims to atraumatically insert the electrode array of the cochlear implant into the cochlea. However, due to the location of the cochlea inside the skull, the surgeon is required to create an access from the surface of the temporal bone to the cochlea (inner ear). In conventional methods, this access is acquired by removal of portions of the mastoid bone through a mastoidectomy and posterior tympanotomy. The outcome and success of the conventional procedure varies due to mainly two factors: surgeon skill and subject anatomical variation. To overcome these variables toward a more consistent and less invasive cochlear implantation surgery, the development of robotic and image guided cochlear implantation has taken place. This study primarily aims to explore the performance of robotic cochlear implantation surgery.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects scheduled for CI surgery according to clinical routine
- •Subjects who will receive a cochlear implant
- •Signed and dated informed consent form
排除标准
- •Lack of compliance with any inclusion criteria
- •Age under 18 years
- •Pregnancy
- •Distance of the planned trajectory to the facial nerve is < 0.4 mm as per screening CT scan
- •Distance of the planned trajectory to the chorda tympani is < 0.3 mm as per screening CT scan
- •A safe inner ear access cannot be planned for preservation of RW membrane and cochlear structures
- •Individuals where image guidance or robotic procedures are not indicated
研究组 & 干预措施
RCI-BE-10
Robot assisted cochlear implant surgery.
干预措施: HEARO (Device)
RCI-BE-10
Robot assisted cochlear implant surgery.
干预措施: OTOPLAN (Device)
结局指标
主要结局
Relative ratio of successful electrode array insertions through the drilled direct cochlear access with the HEARO procedure to the total HEARO procedures.
时间窗: day 0
The primary outcome measure of this study is to explore the relative ratio of the successful electrode array insertions into the cochlea through the drilled direct cochlear access with the HEARO procedure to the total HEARO procedures. Aborted or converted procedures count as procedure in which insertion through the direct cochlea access was not possible. The results will be expressed in relative numbers and in percentage.
次要结局
- Electrode array insertion outcome(day 0)
- Timing of the HEARO procedure(day 0)
- Absolute angular accuracy of the drilled tunnel access(day 0)
- Insertion depth prediction accuracy(day 0)
- Absolute lateral accuracy of the drilled tunnel at the facial recess(day 0)
- Absolute lateral accuracy of the drilled tunnel at the target(day 0)
- Ratio of the round window membrane preservation during the inner ear access(day 0)