NCT02974751Unknown不适用
Global Post-Market Registry Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue
PROCEPT BioRobotics5 个研究点 分布在 5 个国家目标入组 178 人开始时间: 2017年9月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 178
- 试验地点
- 5
- 主要终点
- IPSS score change
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of the AQUABEAM System for the treatment of Lower Urinary Tract Symptoms (LUTS) resulting from Benign Prostatic Hyperplasia (BPH).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction or in urinary retention.
- •Prostate size ≥ 20 mL and ≤ 150 mL as measure by TRUS.
- •Patient is mentally capable and willing to sign a study-specific informed consent form.
排除标准
- •Patients unable to stop anticoagulants, antiplatelet agents, or non-steroidal anti-inflammatory agents (NSAIDs, including aspirin greater or equal to 100mg) prior to treatment per standard of care.
- •History of gross haematuria.
- •Participants using systemic immune-suppressants including corticosteroids (except inhalants), known coagulopathy, or platelet disorder (except aspirin below 100mg/d).
- •Contraindication to both general and spinal anesthesia.
- •Any severe illness that would prevent complete study participation or confound study results.
- •Subject is unwilling to accept a transfusion should one be required.
结局指标
主要结局
IPSS score change
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (5)
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