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临床试验/CTRI/2026/04/108750
CTRI/2026/04/108750尚未招募不适用

Prospective randomised controlled trial to evaluate the efficay of a flexible and navigable suction ureteric access sheath on renal stone clearance compared to conventional access sheath in adult patients of renal stone disease undergoing Retrograde Intrarenal Surgery (RIRS).

AIIMS PATNA1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2026年5月18日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
72
试验地点
1

研究概览

简要总结

Renal calculi are a prevalent urological issue worldwide. Retrograde Intrarenal Surgery (RIRS) has become a primary minimally invasive treatment, especially for upper urinary tract stones.

While effective, conventional RIRS using a standard ureteric access sheath (UAS) has known limitations. Elevated intrarenal pressure during the procedure is a significant concern, increasing the risk of

postoperative fever and sepsis. Furthermore, inefficient removal of stone fragments ("dust") can lead to lower stone-free rates (SFR), potentially requiring secondary procedures. The conventional UAS

can be stiff, posing challenges in tortuous ureters and limiting the evacuation of fragments.

This study aims to address key safety and efficacy challenges in RIRS. A specially designed flexible and navigable suction ureteric access sheath (FANS-UAS) offers potential solutions by reducing

intrarenal pressure, better navigability, and better stone evacuation.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients having renal stone planned for retrograde intrarenal surgery.

排除标准

  • Pregnant female Acute Infection/UTI Coagulopathy Anatomical anomaly.

研究者

发起方
AIIMS PATNA
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

DR VIPIN CHANDRA

AIIMS PATNA

研究点 (1)

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