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临床试验/CTRI/2023/04/051704
CTRI/2023/04/051704已完成4 期

Safety and efficacy of thulium fiber laser versus pneumatic lithotripsy for ureteric stones using semi rigid ureteroscopy

Sai Urology Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年4月20日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Safety and efficacy of Thulium fiber laser versus pneumatic lithotripsy

研究概览

简要总结

Thulium fiber laser is a novel technology used for stone lithotripsy. Because of it’s excellent dusting properties it has the potential to become ideal laser for stone treatment. There is a concern of heat generation and potential trauma to the renal and ureteral mucosa during the use of lasers in renal and ureteral stone treatment. Special concern is for the ureteric stone as the lumen is narrow and the stones are usually impacted. Pneumatic lithotripsy is the standard energy source used for ureteral stone treatment.  We hence propose to evaluate the Safety and efficacy of thulium fiber laser versus Pneumatic Lithotripsy for ureteric stones using semi rigid ureteroscopy

Primary Objective: Safety & efficacy of laser and pneumatic energy source

Secondary Objective: Immediate & long term complications

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
5.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • •All sexes with age ranging from 5- 75 years Patients having clinical and radiological diagnosis of ureteric calculi.

排除标准

  • •Pregnancy Coagulopathy Pyonephrosis Combined renal and ureteric stone.

结局指标

主要结局

Safety and efficacy of Thulium fiber laser versus pneumatic lithotripsy

时间窗: Baseline, 7 days, 30 days, 180 days

次要结局

  • Immediate and long term complications(6 months)

研究者

发起方
Sai Urology Hospital
申办方类型
Private hospital/clinic

研究点 (1)

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