Comparison of the safety, efficacy and stone-free rate of the new flexible and navigable ureteral access sheath with the traditional ureteral access sheath during Retrograde Intrarenal Surgery
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- To evaluate the outcome in terms of stone free rates with the use of flexible and navigable suction (FANS) sheath as compared to the traditional ureteral access sheath (UAS) during retrograde intrarenal surgery (RIRS)
研究概览
简要总结
Flexible and navigable ureteral access sheath (FANS) is the latest development for retrograde intrarenal surgery. With the use of this sheath stone fragments can be sucked out of the kidney. This technology probably can improve the stone-free rate.
The study aims to find out the incidence of stone-free rate using this newer sheath with the traditional ureteral access sheath. The study will also look at the safety and efficacy of the FANS sheath.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)(—)
- 性别
- All
入选标准
- •All patient with renal pelvic and calyceal stones ranging from 10-25 mms undergoing primary or staged RIRS.
排除标准
- •Renal stones more than 25 mms patient unwilling for Retrograde Intrarenal Surgery Urosepsis Bleeding tendencies Pregnancy.
结局指标
主要结局
To evaluate the outcome in terms of stone free rates with the use of flexible and navigable suction (FANS) sheath as compared to the traditional ureteral access sheath (UAS) during retrograde intrarenal surgery (RIRS)
时间窗: 3 month
次要结局
- To evaluate the safety and efficacy of FANS with the traditional UAS during RIRS(3 month)
研究者
Dr Abhay Dinkar Mahajan
Sai Urology Hospital
