A Pilot Proof of Concept Single-arm Study Using PuraStat Following the Aquablation Procedure to Assess Reduction of Hematuria to Allow for Same Day Discharge
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Percentage of Patients Discharged the Same Day as Aquablation
研究概览
简要总结
This is a pilot proof of concept single-arm study using PuraStat following Aquablation procedure to assess reduction of hematuria to allow for same day discharge.
The primary objective is to assess how PuraStat affects post-operative hematuria following Aquablation.
The secondary objective is to assess the number of patients discharged on the same day based on the hematuria criteria (Grade 0 and Grade I).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Any man undergoing Aquablation for LUTS due to BPH
排除标准
- •Unwilling to sign consent
研究组 & 干预措施
Men Undergoing Aquablation
Following the Aquablation procedure for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH), the surgeon will deliver the PuraStat to the prostatic fossa through the cystoscope sheath into the prostate urethra resection bed.
干预措施: PuraStat (Device)
结局指标
主要结局
Percentage of Patients Discharged the Same Day as Aquablation
时间窗: Day 1 (Operative Visit)
次要结局
- Mean Post-Operation Hematuria Grade(Day 1 (Up to Hour 3 Post-Op))
- Percentage of Patients who Experience Dysuria during Follow-Up(Up to Week 4 Post-Operation)