Acute Hemostasis Following the Use of the AQUABEAM® System for the Treatment of Benign Prostatic Hyperplasia III
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Number of subjects that do not require a transfusion and do not return to the operating room for hematuria management within 7 days following the index procedure.
研究概览
简要总结
A dual-arm prospective, interventional clinical trial to evaluate the safety and performance of obtaining hemostasis with catheters along with the use or absence of a hemostatic agent following treatment with the AQUABEAM System.
详细描述
PROCEPT BioRobotics has developed the AQUABEAM, a personalized image-guided waterjet resection system that utilizes a high-pressure saline stream to resect and remove prostate tissue in males suffering from LUTS due to BPH. The primary objective of this study is to evaluate the safety and performance of obtaining hemostasis using balloon catheters with and without hemostatic agents following prostate resection using AQUABEAM for the treatment of LUTS resulting from BPH. Up to 50 participants will be included in the trial at one clinical study site. All patients will be followed up for 3 months for safety assessment prior to study exit. The trial is a dual-arm prospective, interventional clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •BPH symptoms
排除标准
- •Serious concurrent medical conditions
结局指标
主要结局
Number of subjects that do not require a transfusion and do not return to the operating room for hematuria management within 7 days following the index procedure.
时间窗: 7 days post-op
Adequate hemostasis post-Aquablation with the use of a urinary catheter and / or delivery of a hemostatic agent, measured by the number of subjects that, within 7 days following the index procedure, do not require a transfusion and do not return to the operating room for hematuria management.
次要结局
未报告次要终点