Randomized Controlled Trial Comparing the Storz Modulith SLX-F2 and Dornier Delta III Lithotripter Machines
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Stone free rate
研究概览
简要总结
A comparison on the outcomes of patients undergoing shockwave lithotripsy using the Storz machine versus the Dornier machine.
详细描述
This is a single institution, prospective randomized controlled clinical trial comparing two lithotriper machines (the Storz Modulith LX-F2 and Dornier Delta III) in patients who are undergoing shockwave lithotripsy (SWL) as the primary management of their urinary stone. Patients record pain score on day of operation and post-operative day 1, and are followed for 1 month until they receive standard of care imaging at 1 month post-operatively.
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
- •Cleveland Clinic Foundation patients planned for elective SWL with a preoperative CT performed
- •Age ≥ 18 years old
- •Male and female patients
- •Patients of all ethnic backgrounds
- •Stone size 5-15mm
- •Stone location: Renal or proximal ureter
- •Stone density: < 1200 Hounsfield Units
- •Skin to stone distance: < 12cm
- •Primary treatment for a solitary stone (must be previously untreated)
- •Patients must be capable of giving informed consent and must be capable and willing to enroll and participate fully with the study.
排除标准
- •Prior treatment for specified stone
- •Multiple stones on treatment side (even if only one is treated)
- •Anticoagulated or history of coagulopathy
- •Prior ureteral stent placement
- •Technical problems/impossibility of localizing the stone on the day of intervention
- •Patients unable to give informed consent or unwilling to enroll or participate in the study will be excluded.
研究组 & 干预措施
Device Storz Modulith SLX-F2
Patients receive standard of care treatment for their urolithiasis using the Device Storz Modulith SLX-F2
干预措施: Lithotripter (Procedure)
Dornier Delta III Treatment
Patients receive standard of care treatment for their urolithiasis using the Dornier Delta III lithotripter
干预措施: Lithotripter (Procedure)
结局指标
主要结局
Stone free rate
时间窗: Four weeks post operative
Presence of stone on follow up imaging
次要结局
- Fluoroscopy time(Intra-operative)
- Secondary Interventions required(One month post-operative)
- Pain Scores(Four days post-operative)
- Treatment Time(Intra-operative)
- Complication Rates(One month post-operative)