NCT06306534招募中不适用
Intraoperative Acute Study to Evaluate Auditory Intranerve Stimulation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Elicit a typical eABR Wave V with at least 0.2 µV in amplitude and a latency of the peak around 5 ms
研究概览
简要总结
This feasibility clinical investigation is designed to answer the question of whether auditory brainstem responses can be safely elicited by acute electrical stimulation within the human auditory nerve.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Written informed consent
- •Patients who will undergo an acoustic neuroma removal surgery and are functional deaf
- •Age ≥ 18 years
- •Women with childbearing potential: willingness to use a reliable contraceptive method (e.g. copper intrauterine devices or hormonal methods) after consulting their gyncecologists
排除标准
- •Disabilities in addition to hearing impairment which might interfere with the study procedure
- •Pregnant and breast feeding woman or other vulnerable population
研究组 & 干预措施
Insert Array Into Auditory Nerve
Experimental
干预措施: Auditory Nerve Acute (ANA) Electrode Array (Other)
结局指标
主要结局
Elicit a typical eABR Wave V with at least 0.2 µV in amplitude and a latency of the peak around 5 ms
时间窗: 4 weeks
次要结局
- Collection of adverse events(4 weeks)
研究者
研究点 (2)
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