Prospective Clinical Trial To Evaluate The Thulium Fiber Laser For The Ureteroscopic Treatment Of Nephrolithiasis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Mean total operative time
研究概览
简要总结
This is a multi-center, prospective clinical trial to assess the effect of TFL for the lithotripsy of kidney stones.
详细描述
Flexible ureteroscopy is considered the first-line therapy for renal stones < 2 cm. The Holmium: YAG laser (Ho:YAG) is established as gold standard in urology practice. Despite its limitations, it is widely used to break stones into fragments small enough to remove or pass spontaneously through the ureter. Advances in the understanding of laser energy delivery have led to the recent commercialization of the 'Thulium Fiber Laser' (TFL) with unique characteristics and promising improvements of ablation efficiency, dusting capacity, operating time and deflection. A a multi-center, prospective clinical trial to further assess those advantages for the lithotripsy of kidney stones will be conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Solitary renal stone 8 to 20 mm in size or in the case of multiple stones the conglomerate diameter of 8-20 mm is required
- •Must be a suitable operative candidate for flexible ureteroscopy per urologic guidelines
- •Must be 18 years or older
- •Must be able to give consent
- •Bilateral ureteroscopy will be permitted but only the first side will be included in the study
排除标准
- •Concomitant stones in the ureter
- •Prior ipsilateral upper urinary tract reconstructive procedures or history of ipsilateral ureteral stricture
- •Prior radiotherapy to the abdomen or pelvis
- •Neurogenic bladder or spinal cord injury
- •Pregnancy
- •Untreated Urinary Tract Infection (UTI)
结局指标
主要结局
Mean total operative time
时间窗: during the procedure
Total operative time during the ureteroscopic treatment of renal stones using a laser dusting technique.
次要结局
- Rate of stone retropulsion(during the procedure)