NCT06306222招募中不适用
Comparing the Efficacy of Thulium Fiber Laser vs. Holmium:YAG Laser for the Ureteroscopic Treatment of Patients With Urinary Stone Disease: a Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Lithotripsy speed
研究概览
简要总结
This is a randomized controlled trial which aims to compare the efficacy and safety of Thulium fiber laser (TFL) and holmium:yttrium-aluminum-garnet (Ho:YAG) laser ablation during the treatment of upper urinary tract stone disease with flexible ureteroscopy, demonstrating clinical superiority of TFL.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Renal/ureteral stones > 4 mm
排除标准
- •Anatomical abnormalities
研究组 & 干预措施
Holmium:YAG laser lithotripsy
Active Comparator
Holmium:YAG laser lithotripsy represents the gold standard for this procedure since 30 years.
干预措施: Laser lithotripsy (Device)
Thulium fiber laser (TFL) lithotripsy
Experimental
Lithotripsy with TFL is a recently introduced procedure, that will be tested in this study.
干预措施: Laser lithotripsy (Device)
结局指标
主要结局
Lithotripsy speed
时间窗: Through study completion, an average of 1 year
次要结局
- Stone free rate(3 months after the procedure)
研究者
Eugenio Ventimiglia
Principal investigator
IRCCS San Raffaele
研究点 (1)
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