NCT03191734已完成不适用
French Aquablation Clinical Investigation Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue
PROCEPT BioRobotics6 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年9月19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
- 30
- 试验地点
- 6
- 主要终点
- AQUABEAM System Effectiveness: IPSS total score change
研究概览
简要总结
Single arm, multi-center prospective clinical trial to determine the safety and effectiveness of the AQUABEAM System in the treatment of benign prostatic hyperplasia (BPH) in men 45 to 80 years of age.
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
- 45 Years 至 80 Years（Adult, Older Adult）
- 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.
- •History of inadequate response, contraindication or refusal to medical therapy for BPH.
- •Age from 45 through 80 years.
- •Prostate volume between 30mL and 80mL by transrectal ultrasound (TRUS) measured at baseline.
排除标准
- •IPSS total score <
- •History of prostate cancer or clinically significant elevated PSA value.
- •History of bladder cancer actively treated within 2 years prior to the surgical procedure.
- •Bladder calculus or clinically significant bladder diverticulum (e.g., pouch size >20% of full bladder size).
- •Active infection, including urinary tract infection within 72 hours of the treatment procedure.
- •Prostatitis treated with antibiotics within 1 year of the surgical procedure.
- •Subject ever diagnosed with urethral stricture, meatal stenosis, or bladder neck contracture, or has history of damage to external urinary sphincter.
- •Subject has current diagnosis of stress urinary incontinence that requires treatment or daily pad or device use.
- •Clinically significant abnormal serum creatinine measured within 30 days of treatment.
- •Maximum urinary flow rate (Qmax) >15 mL/s or PVR > 300 mL measured by uroflowmetry test at baseline.
- •Subject has been catheterized due to retention within 14 days prior to the surgical procedure.
- •Subject has a history of intermittent self-catheterization.
- •Previous prostate surgery or history of other lower urinary tract surgery such as e.g. urinary diversion, artificial urinary sphincter or penile prosthesis
- •Subjects on anticoagulants or antiplatelet (if medication cannot be stopped before and after procedure) or known coagulopathy (except aspirin below 100mg/d)
- •Any severe illness or psychiatric condition that would prevent study completion or confound study results.
- •Subject taking systemic immune-suppressants including corticosteroids; unable to withhold non- steroidal anti-inflammatory agents (NSAIDs, including aspirin) for 3-5 days prior to treatment except for low dose aspirin (e.g. less than 100mg).
- •Participants using medications specifically for bladder muscle problems (e.g., irritability). Use of medications with anticholinergic or similar properties is allowable provided the patient does not have documented adverse urinary side effects from these medications.
- •Participating in another investigational study that could affect responses to the study device.
- •Subject is unwilling to accept a transfusion should one be required.
研究组 & 干预措施
AQUABEAM System
Experimental
AQUABEAM System
干预措施: AQUABEAM System (Device)
结局指标
主要结局
AQUABEAM System Effectiveness: IPSS total score change
时间窗: 6 Months Post-op
IPSS total score change from baseline to 6 Month
次要结局
未报告次要终点
研究者
研究点 (6)
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