Randomized Clinical Trial Evaluating the Efficiency and Safety of Holmium Laser With Moses Technology Versus SuperPulsed Laser System With Thulium Laser on Renal and Ureteral Stones
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Procedural Time (Minutes)
研究概览
简要总结
The incidence of urinary tract stone disease is increasing. According to the National Health and Nutrition Examination Survey, as of 2012, 10.6% of men and 7.1% of women in the United States are affected by renal stone disease. This has led to an increased demand on Urologists for efficient and safe surgical treatment of stone disease. Over the past two decades, ureteroscopy with laser lithotripsy has become the treatment of choice for most ureteral and renal stones globally. The holmium laser is considered the gold standard for laser lithotripsy. Holmium laser lithotripsy with Moses and the thulium laser are new technologies meant to improve the efficiency of laser lithotripsy. Both are FDA approved treatment modalities for stone disease. Two in vitro studies have compared Moses versus thulium and shown that thulium has higher ablative volumes then the holmium laser with Moses, but no clinical trials have compared the two treatment modalities.
In this study, investigators are going to conduct a prospective, randomized clinical trial to determine whether there is a difference in procedural time, intraoperative parameters or stone free rate between the Holmium laser with Moses and the thulium laser. This is significant as this may lead to shorter overall operative times, which may result in decreased operative costs and complications.
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with renal or ureteral urinary stones who require endoscopic treatment in the outpatient operating room
- •Participant's stone size in a single renal unit of 3-10 mm and 11-20 mm. Stone size is defined as the largest diameter of a single stone on pre-operative CT. Participants with multiple stones will be included as long as their largest stone size falls within the above parameters.
排除标准
- •Participants under 18 years of age and over 89 years old.
- •Pregnant participants
- •Participants with transplant kidneys
- •Participants with irreversible coagulopathy
- •Participants with known ureteral stricture disease
- •Participants who do not have a pre-operative CT.
- •Non-English speaking, vulnerable participants such as lacking of decision-making capability, prisoner, adult unable to consent, will not be enrolled.
结局指标
主要结局
Procedural Time (Minutes)
时间窗: up to 6 hours
Time from the minute the ureteroscope is inserted into the participant to the time the ureteroscope has been removed will be reported as procedural time.
次要结局
- Ablation Speed(0-6 hours)
- Stone Free Rate(Baseline(pre-operative) and approximately 8 weeks)
- Total Energy Used (Kilojoules)(up to 6 hours)
- Number of Participants With Post-operative Complications(approximately 8 weeks (1 month post-operative))
- Lasing Time (Minutes)(up to 6 hours)
- Ablation Efficiency (J/mm^3)(up to 6 hours)
- Score on the Laser Evaluation Instrument(Up to 6 hours)
- Change in Quality of Life Survey (WISQOL Short Form) Both Pre-operatively and Post-operatively(Baseline(pre-operative) and approximately 8 weeks (1 month post-operative))