NCT06948331尚未招募2 期
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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 25
- 试验地点
- 2
- 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
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)
研究者
研究点 (2)
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