The Efficacy of a Minimally Invasive Direct Cochlear Access Via the HEARO Procedure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Electrode array insertion
研究概览
简要总结
The objectives of this study are to explore the efficacy and safety of a robotic procedure for a minimally invasive cochlear implantation.
详细描述
The cochlear implant (CI) is a neural prothesis and has been the gold standard treatment for severe to profound sensorineural hearing loss over several decades. The surgical procedure for cochlear implantation surgery 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 initially 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 large portions of the mastoid bone through a wide 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 efficacy of the HEARO robotic cochlear implantation surgery.
Primary Objective
The primary objective of this study is to:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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 of the MED-EL portfolio
- •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
- •Individuals who have known allergy to components of the cochlear implant
结局指标
主要结局
Electrode array insertion
时间窗: During surgery
• Relative ratio of successful electrode array insertions through the drilled direct cochlear access with the HEARO procedure to the total HEARO procedures (i.e. proportion of successful insertions with the procedure out of the total number of patients included in the study).
次要结局
- Insertion depth prediction accuracy (efficacy)(During surgery)
- Adverse events (safety)(During surgery)
- Timing of the HEARO procedure(During surgery)
- Absolute lateral accuracy of the drilled tunnel at the target (safety)(During surgery)
- Absolute angular accuracy of the drilled tunnel access (safety)(During surgery)
- Ratio of the round window membrane preservation during the inner ear access (safety)(During surgery)
- Electrode array insertion outcome (efficacy)(During surgery)