DRKS00019939已完成1 期
Preliminary evaluation of a new method to place an EMG electrode into the Stapedius muscle for recording a specific eSRT signal - /
MED-EL Elektromedizinische Geräte GmbH0 个研究点目标入组 18 人开始时间: 2020年3月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Age = 18 years
- •Measurable acoustical stimulation of the Stapedius reflex
- •Need of a cochlear implantation
- •Anatomic, physiological and mental conditions compatible with the participation in this clinical Investigation
- •High motivation with realistic expectations regarding the participation in this clinical investigation
- •Signed and dated informed consent before the start of any investigational procedure
排除标准
- •Lack of compliance with any inclusion criteria
- •Pregnant or breast-feeding women
- •Known allergies or intolerance to the material used for this clinical investigation
- •Current participation in other drugs and/or medical device clinical investigations that can affect the results of the present clinical investigation
- •Other clinical diseases that might result in alteration of the results of this clinical investigation
- •Anything that, in the opinion of the Principal Investigator, would place the subject at increased risk or preclude the subject's full compliance with the general requirements of this clinical investigation.
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