The Efficacy of a Minimally Invasive Direct Cochlear Access Via the HEARO Procedure
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- The relative ratio of the electrode array insertion into the cochlea through the drilled direct cochlea access with HEARO procedure. (Efficacy)
研究概览
简要总结
To study the efficacy of a minimally invasive direct cochlear access via the HEARO procedure.
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
- •Adult cochlear implant candidates with suitable anatomy opting for a MED-EL cochlear implant.
排除标准
- •Age under 18 years
- •Pregnancy
- •Distance of the planned trajectory to the facial nerve is < 0.4mm
- •Distance of the planned trajectory to the chorda tympani is < 0.3mm
- •Vulnerability
- •Invalid or withdrawn informed consent
结局指标
主要结局
The relative ratio of the electrode array insertion into the cochlea through the drilled direct cochlea access with HEARO procedure. (Efficacy)
时间窗: Image data aquired during the procedure
The ratio of the number of the procedures in which it was possible to insert the electrode inside the cochlea through the direct cochlear access compared to the number of procedures in which the insertion through the direct cochlea access was not possible will be calculated. 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 (n of 25) and in percentage (%).
次要结局
- Electrode array insertion depth (Efficacy)(The procedure (day 0))
- Absolute angular accuracy of the drilled tunnel access(The procedure (day 0))
- Number of correctlly inserted electrode contact (Efficacy)(The procedure (day 0))
- Insertion depth prediction accuracy (Efficacy)(The procedure (day 0))
- Absolute lateral drilling accuracy of the drilled tunnel at the level of facial recess (Safety)(The procedure (day 0))
- Absolute lateral drilling accuracy of the drilled tunnel at the target (Safety)(The procedure (day 0))
- Evaluation of the automatic landmark detection (Performance)(The procedure (day 0))
研究者
Prof. Vedat Topsakal
Principal Investigator
University Hospital, Antwerp