NCT02641795终止不适用
Robotic Assisted Cochlear Implantation Feasibility Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Drilling accuracy
研究概览
简要总结
A first in man clinical trial to asses the the use of am image guided robotic system to safely and effectively create a minimally invasive access tunnel to the middle ear cavity to allow access to the round window for cochlear implant electrode insertion.
详细描述
A first in man feasibility study of an image guided robotic system for performing a key-hole approach to the middle ear cavity.
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
- •Geographically and physically able to attend scheduled evaluations and follow-up appointments
- •Indicated for cochlear implantation
- •Age 18 years or older
- •Fluent in German or French
- •Sufficient facial recess size ( > 2.5 mm between the facial nerve and chorda tympani)
排除标准
- •Pregnancy
- •Anatomical malformation of the middle or inner ear or unusual facial nerve course
- •Lack of compliance with any inclusion criteria
研究组 & 干预措施
Experimental
Experimental
Minimally invasive robotic cochlear implantation with custom device
干预措施: Minimally invasive robotic cochlear implantation (Device)
结局指标
主要结局
Drilling accuracy
时间窗: Image data acquired during the procedure
The lateral distance between the center lines of the planned and drilled tunnel positions at the level of the facial nerve measured from medical image data
次要结局
- Invasiveness of the intervention(The procedure (day 0))
- Number of successfully completed robotic procedures(The procedure (day 0))
- Registration accuracy(The procedure (day 0))
- Time of the robotic procedure and its subparts(The procedure (day 0))
- Adverse events(day 0-30)
- Blood loss(The procedure (day 0))
- The number of successful cochlear implant electrode array insertions(The procedure (day 0))
- Postoperative pain(day 0-30)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
The Performance of a Robot-assisted Minimally Invasive Direct Cochlear Access for Cochlear ImplantationSensorineural Hearing LossNCT04610450Insel Gruppe AG, University Hospital Bern3
已完成
不适用
Development of a Robotic Minimally Invasive Pathway for Cochlear ImplantationImplantCochlear Hearing LossNCT04048239Centre Hospitalier Universitaire, Amiens9
招募中
不适用
Clinical Evaluation of Robot-assisted Cochlear Implant Insertion in Adults Using RobOtol® Compared to Manual InsertionProfound Bilateral Hearing LossNCT05696171Nantes University Hospital550
Unknown
不适用
First Clinical Evaluation of HEARO Robotic Cochlear Implantation Surgery in AustriaDeafnessNCT04795986Medical University of Vienna10
进行中（未招募）
不适用
A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing LossHearing Loss, Bilateral or UnilateralHearing Loss, SensorineuralHearing Loss, CochlearNCT06642935Cochlear18