Superpulsed Thulium Fiber Laser VS. Pulse Modulated High Power Holmium:YAG Laser For Retrograde Intrarenal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Number of Participants With Stone Free Status
研究概览
简要总结
This is a randomized prospective study to compare stone free rates and operative efficiency of two laser systems used during retrograde intrarenal surgery for kidney stone disease:
- A superpulsed thulium fiber laser (thulium)
- A pulse modulated high power holmium laser (Holmium)
详细描述
This is a randomized prospective study. The purpose is to compare the stone free rate and operative efficiency of two leading contemporary laser systems used during retrograde intrarenal surgery for kidney stone disease. The researchers will compare the following two systems:
- A superpulsed thulium fiber laser (thulium)
- A pulse modulated high power holmium laser (Holmium)
The researchers will recruit 82 subjects undergoing single stage unilateral ureteroscopy for renal stones with a volume between >5mm to < 20 mm. Subjects will be randomized to undergo lithotripsy with either Ho:YAG or Thulium lasers.
All subjects will undergo surgical interventions that abide by broadly accepted guidelines and standards of care.
The primary outcome is stone free rate evaluated by postoperative CT scans done 6-12 weeks after surgery.
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
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Participants With Stone Free Status
时间窗: 6-12 weeks postoperative
Stone free status as determined by 6-12 week postoperative CT scan to assess laser efficacy
次要结局
- Fragmentation Speed(Intraoperatively (Day 1))
- Lasing Activity(Intraoperatively (Day 1))
- Energy Utilization(Intraoperatively (Day 1))
研究者
Mantu Gupta
Professor of Urology
Icahn School of Medicine at Mount Sinai