NCT04577118已完成不适用
The iotaSOFT Insertion System Safety Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Number of Subjects Experiencing a Peri-procedural Adverse Event Due to Use of the iotaSOFT Insertion System During Cochlear Implant Surgery
研究概览
简要总结
Non-significant risk evaluation of the iotaSOFT Insertion System when used by a surgeon to assist with inserting a cochlear implant electrode array.
详细描述
This is a confirmatory study to assess successful peri-procedural use of the iotaSOFT Insertion System and potential adverse events that may be caused by use of the system during cochlear implant surgery.
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
- •Candidate for cochlear implantation per indications
- •Age 18 years or older
排除标准
- •Prior cochlear implantation in ear to be treated
- •Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode ray
- •Craniofacial abnormality or abnormal cochlear/nerve anatomy on pre-operative CT or MR imaging
- •Deafness due to lesions of the acoustic nerve or central auditory pathway
- •Diagnosis of auditory neuropathy
- •Active middle ear infection
结局指标
主要结局
Number of Subjects Experiencing a Peri-procedural Adverse Event Due to Use of the iotaSOFT Insertion System During Cochlear Implant Surgery
时间窗: Day 0
Number of subjects experiencing a peri-procedural adverse event due to use of the iotaSOFT Insertion System and descriptions of reported adverse events. AEs will be summarized by type and number of subjects experiencing an event.
次要结局
- Successful Surgical Use of the iotaSOFT Insertion System During Cochlear Implant Surgery as Measured by a Surgeon Utility Questionnaire. The Questionnaire Will be Used to Calculate the Proportion of Subjects in Which the Device Performed as Intended.(Day 0)
研究者
研究点 (2)
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