NCT03643380已完成1 期
Acute Study to Evaluate a Novel Implantable Midfield Powered Device in Humans With Urinary Incontinence
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Sacral Nerve Response measured by observed bellow response and big toe flexion
研究概览
简要总结
A pre-market, prospective, non-randomized acute feasibility study for the treatment of patients with urinary incontinence (UI) as a consequence of urinary incontinence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject was eligible for treatment and indication for the Medtronic InterStim system or InterStim II
- •Subject wished to undergo an InterStim or InterStim II implant procedure after this acute clinical investigation
- •Subject was in good health in the opinion of the investigator
- •Subject was able to understand and voluntarily signed and dated the Ethics Committee approved informed consent form prior to initiation of any screening or study-specific procedures
- •Subject was minimum of 18 years and maximum of 65 years of age
排除标准
- •Subject had any of the contraindications for the InterStim system or InterStim II system
研究组 & 干预措施
Investigational SNS device
Experimental
干预措施: AHLeveeS System (Device)
结局指标
主要结局
Sacral Nerve Response measured by observed bellow response and big toe flexion
时间窗: Procedure
Stimulation of the S3 sacral nerve measured by observed bellows response and big toe flexion
AHLeveeS System placement in the S3 foramen assessed by fluoroscopy image
时间窗: Procedure
Confirm that the AHLeveeS System can be correctly placed and inserted in close proximity of the sacral nerve in the S3 foramina assessed by fluoroscopy image
次要结局
未报告次要终点
研究者
研究点 (2)
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