NCT04556201已完成不适用
A Prospective, Multicenter, Post-Market Clinical Registry to Collect Real-World Evidence on the Clinical Performance of the SOLTIVE™ Laser for Treatment of Kidney or Ureteral Stones
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 13
- 主要终点
- Stone free rate
研究概览
简要总结
The purpose of this study is to collect real-world evidence on the performance of the SOLTIVE™ Premium SuperPulsed Laser System for laser lithotripsy in ureteroscopy, percutaneous nephrolithotomy (PCNL) and mini PCNL for kidney and ureteral stones.
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
- •≥18 years of age
- •Medical indication for ureteroscopy, percutaneous nephrolithotomy (PCNL) or mini PCNL
- •Willing and able to provide informed consent
- •Female and of childbearing age with a negative pregnancy test
排除标准
- •Contraindicated for uteroscopy, PCNL or mini PCNL as determined by the physician
- •Inability to tolerate anesthesia for any reason
- •Unable or unwilling to provide informed consent
- •Concurrently participating in another competing clinical study
- •Known ureteral stricture
- •Unwilling or unable to return for follow-up
结局指标
主要结局
Stone free rate
时间窗: 3 month
Stone free rate as determined by standard of care imaging
次要结局
- Device deficiencies(During procedure)
- Total laser energy time(During procedure)
- Total procedure time(During procedure)
- Accessory devices used(During procedure)
- Adverse events(At procedure, immediate post-procedure, 1 month follow-up and 3 month follow-up)
- Rate of treatment/interventions needed(At 1 month follow-up and 3 month follow-up)
研究者
研究点 (13)
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