NCT05896345已完成不适用
Shockwave Lithotripsy (SWL) Versus SWL and Oral Dissolution Therapy (ODT) For Paediatrics Radiolucent Renal Stone. A Randomised Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Assess the stone free rate measured by computed tomograghy as asymptomatic insignificant residual fragments less than 3 mm
研究概览
简要总结
To conduct a RCT comparing SWL versus combined ODT and SWL as non-invasive methods for management of paediatrics radiolucent renal stone.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1-2.5 cm renal stone
- •Normal Serum creatinine
- •Radiolucent stone with Hounsfield units less than 400
排除标准
- •Bleeding diatheses.
- •Patients with a pacemaker.
- •uncontrolled UTIs.
- •Severe skeletal malformations.
- •Arterial aneurysm in the vicinity of the stone.
- •Anatomical obstruction distal to the stone.
研究组 & 干预措施
SWL
Active Comparator
Shockwave Lithotripsy (SWL)
干预措施: SWL (Device)
SWL and ODT
Active Comparator
Shockwave Lithotripsy (SWL) and Oral Dissolution Therapy (ODT)
干预措施: SWL and ODT (Combination Product)
结局指标
主要结局
Assess the stone free rate measured by computed tomograghy as asymptomatic insignificant residual fragments less than 3 mm
时间窗: 3 month
percentage of patient who are stone free
次要结局
未报告次要终点
研究者
研究点 (1)
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