NCT03746613已完成不适用
Clinal Evaluation of Navigation Based Functional Ear Surgery Using Image Guided and Robotically Assisted Techniques
Prof. Vedat Topsakal1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2018年9月24日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- The relative ratio of successfully completed procedures where a direct access tunnel was drilled to the cochlea with the HEARO® system and the electrode was conventionally inserted through the tunnel.
研究概览
简要总结
To assess the feasibility of achieving a minimally invasive access to the inner ear through the navigation-based HEARO procedure and subsequently insert the electrode array of the cochlear implant through the access.
详细描述
- Demonstrate the feasibility and efficacy of performing a middle and inner ear access for cochlear implantation procedures in adults.
- Validate the procedure workflow including imaging, planning, safety assessment, image to patient registration, robotic drilling, electrode insertion and device implantation.
- Validate the system and procedure safety mechanisms.
- Collect required data for validation of safety algorithms and procedure workflow optimisation.
- Validate the HEARO system.
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 suffering from profound sensorineural deafness requiring a Cochlear implant
排除标准
- •Age under 18 years
- •Pregnant women
- •Anatomical anomalies of temporal bone
- •Chronic otitis media with or without cholesteatoma
研究组 & 干预措施
Minimally invasive robotic cochlear implantation with HEARO
Experimental
干预措施: HEARO (Device)
结局指标
主要结局
The relative ratio of successfully completed procedures where a direct access tunnel was drilled to the cochlea with the HEARO® system and the electrode was conventionally inserted through the tunnel.
时间窗: Image data aquired during the procedure
次要结局
- Time of procedure(The procedure (day 0))
- Volume of tissue removed(Image data aquired during the procedure)
- Number of completed middle ear access(The procedure (day 0))
- Number of completed inner ear access(The procedure (day 0))
- Accuracy of the drilled trajectory(Image data aquired during the procedure)
- Sensitivity and specificity of facial nerve monitoring(The procedure (day 0))
- Measurement of the insertion angle(Image data aquired during the procedure)
- Number of tip fold-overs(The procedure (day 0))
- Number of Scala deviations(The procedure (day 0))
- Number of complication events on (temporary) facial nerve palsy, pre and post bleeding and infection(day 0-30)
研究者
Prof. Vedat Topsakal
Principal Investigator
University Hospital, Antwerp
研究点 (1)
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