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临床试验/NCT03608098
NCT03608098撤回不适用

Long Pulse Versus Short Pulse Laser Dusting for Renal Stones

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家开始时间: 2019年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Stone free rate

研究概览

简要总结

The purpose of this research study is to compare how well two treatments work for removing kidney stones. The two study groups include ureteroscopy with long/short pulse lithotripsy to remove kidney stones. Both of these options are considered standard of care and are used currently in surgery.

详细描述

This study will compare two types of laser lithotripsy to see the pulse duration to determine which settings are more effective. This is a randomized control trial with subjects randomized to either long pulse or a short pulse group. Those subjects with a single kidney/ureter stone measuring up to 20 mm will be eligible for the study. The procedures will be performed using the standard of care instruments and techniques but the pulse type setting in surgery will be constant. Some Holmium laser devices provide the option to modulate the pulse duration. A longer laser pulse duration (700 μs or 1500 μs) as compared to a traditional pulse duration (300 μs or 350 μs) has been demonstrated in vitro studies to provide effective stone disintegration while reducing laser fiber tip degradation and stone retropulsion. Both the long and the short setting can dust the stone and currently we alternate in each procedure from one setting to the other and it is unclear which setting is more effective. No changes to operative technique will be performed for subjects in the study vs regular patients undergoing the same procedure. All subjects will be seen one week to one month after surgery for stent removal and follow up.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Kidney/ureter single stone between up to 2 cm
  • Age over 18 years
  • Two kidneys

排除标准

  • Solitary Kidney
  • Age under 18
  • Pregnancy

研究组 & 干预措施

Short Pulse Duration Group

Active Comparator

A short pulse duration (300 μs or 350 μs) will be used in this group.

干预措施: Short Pulse Duration (Device)

Long Pulse Duration Group

Active Comparator

A long laser pulse duration (700 μs or 1500 μs) will be used in this group.

干预措施: Long Pulse Duration (Device)

结局指标

主要结局

Stone free rate

时间窗: 1 month after surgery

Proportion of participants free of stones after procedure reported by group

次要结局

  • Operative duration time(1 month after surgery)
  • Need for Secondary Procedures(1 month after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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