NCT00959153Unknown3 期
Extracorporeal Shock Wave Lithotriptor Indicated for Fragmenting Urinary Stones in the Kidney (Renal Pelvis)
Advance Shockwave Technology GmbH3 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年6月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- stone fragmentation
研究概览
简要总结
A total of 20 subjects presenting with urinary stone(s) in the kidney or ureter will be treated with an extracorporeal shockwave lithotripsy device to fragment the stones. Subjects will be followed for 14 days. If at the 14 day follow-up visit the subject continues to present with a stone size 4 mm or greater will have an option of retreatment or other intervention. If the subject consents to be retreated at this time, this subject will be followed up for another 14 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Diagnosis of a solitary Urinary stones in the renal pelvis or renal calyces or ureter
- •Presence of one stone greater than 4 mm and less than 12 mm
排除标准
- •Urinary tract obstruction, acute or unresolved cholecystitis, cholangitis, pancreatitis or obstruction of the biliary duct system
- •Impaction of stone to be treated
- •Staghorn stones
- •Failed or inadequate lithotripsy procedure within 3 months prior to study
- •Coagulation abnormalities or anticoagulation therapy
- •Pregnant or females of child-bearing potential General, spinal or epidural anesthesia is contraindicated
- •Can not be positioned correctly for fluoroscopic imaging
结局指标
主要结局
stone fragmentation
时间窗: 14 days
次要结局
未报告次要终点
研究者
研究点 (3)
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