Development of a Robotic Minimally Invasive Pathway for Cochlear Implantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- surgical quality based on material description and surgical technique
研究概览
简要总结
Cochlear Implantation is a system developed to restore hearing in people with profound sensorineural hearing loss, whose classical hearing aids are ineffective. Surgery is necessary to insert the internal part into the cochlea and requires milling the mastoid to access the round window. This approach is technically difficult, and is performed under a microscope by an experienced surgeon. The development of a surgical technique that is both safer and less invasive is currently possible thanks to robotics.
详细描述
The ROSA robot coupled to the O-Arm scanner will guide the milling to the round window, whose path has been previously modeled, with the identification of the facial nerve. Milling will be done in 2 stages with a CT (computerised tomography scan) and electromyographic verification of the facial nerve. The insertion of the implant will be performed manually under endoscopic control. The preoperative and postoperative course of the patient will be identical.
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
- •patients eligible for cochlear implantation in CHU Amiens
- •patient more than 18 years old.
排除标准
- •malformation or significant antecedent of mastoidectomy
结局指标
主要结局
surgical quality based on material description and surgical technique
时间窗: during surgery, day 1
surgical quality based on material description and surgical technique
cochlear implantation with the ROSA robot surgery time
时间窗: during surgery, day 1
cochlear implantation with the ROSA robot surgery time
次要结局
- surgical quality based on robot precision(during surgery, day 1)
- surgical quality based on the cochlear implantation in the cochlea(during surgery, day 1)
- surgical quality based on intraoperative electrophysiological data(during surgery, day 1)
- surgical quality based on pathological complications(during surgery and postoperative period (1.5 month after surgery))