Evaluating the Safety and Effectiveness of Steerable Ureteroscopic Renal Evacuation (SURE) With the CVAC® System Compared to Standard Ureteroscopy With no Suction for the Treatment of Renal Stones: a Prospective, Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 5
- 主要终点
- Residual Stone Volume (RSV)
研究概览
简要总结
The goal of this clinical trial is to compare Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System and standard ureteroscopy (URS) with laser lithotripsy for the treatment of urolithiasis. This is a prospective, randomized (1:1), multi-center study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidate for ureteroscopy with laser lithotripsy
- •Be willing and able to return for and respond to all study-related follow up procedures
- •Have been informed of the nature of the study and has provided informed consent using the IRB approved informed consent (ICF)
排除标准
- •Untreated urinary tract infection at the time of the index procedure
- •Significant comorbidities
- •Bladder, ureteral or kidney abnormalities
- •Pregnant individuals
- •Unable to meet the treatment and follow up protocol requirements
研究组 & 干预措施
Steerable Ureteroscopic Renal Evacuation (SURE) with CVAC System
The CVAC Aspiration System is a sterile, single use, steerable ureteral catheter system with integrated vision, irrigation and aspiration for the treatment and removal of urinary stones (kidney stones, fragments, and dust).
干预措施: Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System (Device)
Standard Ureteroscopy (URS)
This is a treatment in which the urologist uses a laser to break a kidney stone into very small pieces and then places a tool called a stent to allows the remaining pieces to fall out.
干预措施: Standard Ureteroscopy (URS) (Device)
结局指标
主要结局
Residual Stone Volume (RSV)
时间窗: 30-Day
Residual Stone Volume (RSV)
时间窗: 30-Day
次要结局
未报告次要终点