NCT03167294已完成不适用
PROCEPT AQUABEAM Study for the Treatment of Benign Prostatic Hyperplasia (ABS)
PROCEPT BioRobotics2 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2014年12月14日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Primary Device Performance Endpoint
研究概览
简要总结
Single-arm prospective, interventional clinical trial. Results will be compared to a historical control in the treatment of benign prostatic hyperplasia
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •50 - 80 years
- •Moderate to severe BPH
- •Subjects who have failed standard medical therapy
排除标准
- •Size and width of prostate
- •Medical condition or co-morbidities where BPH intervention would be contraindicated
研究组 & 干预措施
Single Arm
Other
AquaBeam System for resection and removal of prostatic tissue in males suffering from BPH
干预措施: AquaBeam System (Device)
结局指标
主要结局
Primary Device Performance Endpoint
时间窗: 6 months
The primary device performance endpoint is completion of the intended surgical procedure.
Primary Safety Endpoint of the study is the perioperative complication rate.
时间窗: 6 months
The primary safety endpoint of the study is the perioperative complication rate
次要结局
未报告次要终点
研究者
研究点 (2)
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