PuraStat for Aquablation Day Case (Use of PuraStat Following an Aquablation Procedure)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Hematuria grade at 1-3 hours postop in the PACU
研究概览
简要总结
Randomized, single-blinded investigational study to assess the safety of PuraStat following the Aquablation procedure
详细描述
This study will evaluate the safety and effectiveness of a device (PuraStat hydrogel and the syringe used to apply it - referred to as PuraStat, designed to help control bleeding after the subject's scheduled Aquablation procedure. To assess its effectiveness, investigators will take a picture of the color of your urethral Foley catheter and grade the amount of blood present 1-3 hours after surgery. Investigators will also examine whether the device helps subjects recover more quickly and be discharged the same day, which currently happens in only 1% of cases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subject must be undergoing Aquablation
- •Subject is willing to comply with protocol requirements
排除标准
- •Any significant medical condition which, in the attending physician's opinion, may interfere with the patient's optimal procedure
- •Known or suspected systemic or severe infection
- •Patient unable to give consent
结局指标
主要结局
Hematuria grade at 1-3 hours postop in the PACU
时间窗: 1 to 3 hours post procedure
Grade the amount of blood present 1-3 hours after surgery Scale zero through Five
次要结局
- Percentage of patients discharged on the same day(Postoperative Week 1)
- Patient Reported Outcome Measure IPSS questionnaire(From Enrollment to 30 days post procedure)
- Patient Reported Outcome Measures LURN SI-29 questionnaire(From Enrollment to 30 days post procedure)
- Patient Reported Outcome Measures SHIM questionnaire(From Enrollment to 30 days post procedure)
- Patient Reported Outcome Measures MSHQ-EjD questionnaire(From Enrollment to 30 days post procedure)
- Patient Reported Outcome Measures Dysuria questionnaire(30 days post procedure)
研究者
Alexander Glaser
Vice Chief of Urology and Director of Urology Research, Endeavor Health
Endeavor Health