NCT04795986Unknown不适用
First Clinical Evaluation of HEARO Robotic Cochlear Implantation Surgery in Austria
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- efficacy of cochlear access
研究概览
简要总结
To demonstrate the efficacy of a minimally invasive direct cochlear access via the HEARO procedure in cochlear implantation.
详细描述
The HEARO procedure involves a robot which drills the access to the cochlear in cochlear implantation.
The study is an observational study of the first implementation in clinical routine in Austria.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（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
- •Pregnant women
- •Facial recess size does not allow a minimum distance of 0.4mm from the planned trajectory to the facial nerve and 0.3mm to the chorda tympani
- •Vulnerable or mentally retarded candidates
- •Invalid or withdrawn informed consent
结局指标
主要结局
efficacy of cochlear access
时间窗: at implantation
Percentage of patients with successful cochlear access with the hearo procedure (successful meaning no conventional mastoidectomy and posterior tympanotomy necessary)
次要结局
- electrode array insertion outcomes(at implantation)
- Safety of cochlear access(at implantation)
研究者
Christoph Arnoldner
Assoc.-Prof. Priv.-Doz. Dr.
Medical University of Vienna
研究点 (1)
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