The Canadian StoneBreakerTM Trial: A Randomized, Multicentre Trial Comparing The LMA StoneBreakerTM and the Swiss LithoClastR During Percutaneous Nephrolithotripsy.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Time to complete fragmentation of renal calculi treated via PNL
研究概览
简要总结
The purpose of this study is to compare the LMA StoneBreakerTM to the current standard of pneumatic lithotripsy, the Swiss LithoClastR, during percutaneous nephrolithotripsy (PNL).
详细描述
Objective:
The purpose of this study is to compare the LMA StoneBreakerTM to the current standard of pneumatic lithotripsy, the Swiss LithoClastR, during percutaneous nephrolithotripsy (PNL).
Rationale:
Percutaneous nephrolithotripsy (PNL) is the preferred treatment modality for renal stones greater than 2cm in diameter.
The pneumatic lithotriptor functions as a pneumatic jackhammer, providing either a single pulse or a train of pulses at 2Hz as determined by the operator. Its chief advantage is its ability to fragment even the hardest calculi. The pneumatic lithotriptor, while extremely effective, does not utilize thermal energy and therefore has no risk of thermal damage to the surrounding tissue. The pneumatic lithotriptor currently in use, the Swiss LithoClast is powered by compressed medical air. The primary disadvantage of this device is that the residual calculi must be individually removed with forceps following fragmentation.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients over the age of 18 undergoing PNL
- •Previously untreated renal stones
- •Patients with 3 or less individual renal calculi, accessible with a rigid nephroscope
- •Stones must be at least >225mm2 area on KUB
- •Patient must have a CT scan prior to treatment
排除标准
- •Patients with an active contraindication for PNL (pregnancy, uncorrected coagulopathy, active urinary infection, contrast allergy)
- •Partial staghorn calculi
- •Complete staghorn calculi
- •Stones in calyceal diverticulum
- •Cases requiring multiple tracts
结局指标
主要结局
Time to complete fragmentation of renal calculi treated via PNL
时间窗: During surgery
次要结局
- Time to removal of large fragments using graspers & time required with US to remove small fragments/dust(During surgery)