NCT03651024Unknown不适用
A Prospective, First in Human Study to Evaluate the Safety and Performance of a Flow Modification System
Sano V Pte Ltd0 个研究点目标入组 10 人开始时间: 2018年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 主要终点
- The surgical implant for ED treatment
研究概览
简要总结
A Prospective, First in Human Study to Evaluate the Safety and Performance of a Flow Modification System
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
- 25 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient understands and has signed the study informed consent form.
- •Documented history of erectile dysfunction
- •Sexually active
排除标准
- •Current participation in any clinical study with any investigational drug or device.
- •2. Patient is known or suspected not to tolerate the procedure, including exposure to contrast
- •Active infection or fever that may be due to infection
- •Life expectancy < 2 years due to other illnesses
结局指标
主要结局
The surgical implant for ED treatment
时间窗: 12 months
Primary Safety Endpoint • 30-day Freedom from Major Adverse Events
次要结局
未报告次要终点
研究者
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