A Retrospective, Multi-center Real-world Study of Steerable Ureteroscopic Renal Evacuation (SURE) Procedure With the CVAC® System
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Stone free Status
研究概览
简要总结
This is a retrospective, multi-center collaboration to assess real-world outcomes of a novel steerable aspiration system, the CVAC® System ("CVAC"), and flexible and navigable suction ureteral access sheath (FANS) for the treatment of urinary stones.
详细描述
The objective of this study is observation of the safety and efficacy of subjects who underwent SURE procedure using the CVAC System or FANS for the removal of kidney stones in candidates for URS with laser lithotripsy. Efficacy will be observed by reviewing stone free status on standard of care post-procedure imaging. Safety will be observed by reviewing procedural information and if subjects had urologic events leading to Emergency Department (ED) visits, hospitalization, or retreatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Subjects that had SURE procedure with CVAC System performed in the retrospective cohort
- •Subjects that had flexible URS (fURS) procedure with FANS performed in the retrospective cohort
排除标准
- •For planned SURE procedures, the inability for CVAC to gain access required for treatment of kidney stones
结局指标
主要结局
Stone free Status
时间窗: Post-Operative up to 90 Days
Completed by reviewing any available standard of care post-procedure imaging
Intra- & Post-Operative Complications
时间窗: Intra- & Post-Operative up to 90 Days
Completed by reviewing data available for intra- and post-op complications
次要结局
未报告次要终点