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临床试验/NCT03125863
NCT03125863已完成不适用

Acute Hemostasis Following the Use of the AQUABEAM® System for the Treatment of Benign Prostatic Hyperplasia

PROCEPT BioRobotics2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2016年8月26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
21
试验地点
2
主要终点
Completion of the intended surgical procedure

研究概览

简要总结

A single-arm prospective, interventional clinical trial to evaluate the safety and performance of obtaining hemostasis with commercially approved catheters following prostate resection using the AquaBeam for treatment of LUTS resulting from BPH.

详细描述

PROCEPT BioRobotics has developed the AquaBeam, a personalized image-guided waterjet resection system that utilizes a high-velocity saline stream to resect and remove prostate tissue in males suffering from Lower Urinary Tract Symptoms (LUTS) due to BPH. The AquaBeam System is intended for the resection and removal of prostate tissue in patients experiencing LUTS. The primary objective of the study is to evaluate the safety and performance of obtaining hemostasis with commercially approved catheters following prostate resection using the AquaBeam. The time frame of the study is 7 days. Up to 30 participants will be included in this single-site clinical trial. The trial is a single-arm prospective, interventional clinical study. Results will be analyzed to determine the safety and efficacy of commercially approved catheters for the achievement of acute hemostasis without the need for cauterization.

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
40 Years 至 85 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Male age from 40 through 85 years with LUTS due to BPH

排除标准

  • Any severe illness that would prevent complete study participation or confound study results

研究组 & 干预措施

Treatment Arm

Experimental

Subjects will receive treatment with the AquaBeam System to remove enlarged prostatic tissue. Following the aquablation intervention, a urinary catheter will be inserted to apply pressure on treated tissue for hemostasis.

干预措施: AquaBeam System (Device)

结局指标

主要结局

Completion of the intended surgical procedure

时间窗: 7 days post-op

Proportion of subjects that require electrocautery or any other intervention post catheter removal.

时间窗: 7 days post-op

次要结局

未报告次要终点

研究者

发起方
PROCEPT BioRobotics
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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