跳至主要内容
临床试验/CTRI/2024/01/062036
CTRI/2024/01/062036招募中3 期

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

Sai Urology Hospital1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2024年2月1日最近更新:

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

发起方
Sai Urology Hospital
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Dr Abhay Dinkar Mahajan

Sai Urology Hospital

研究点 (1)

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