RetroPerc®-A Prospective, Multi-institutional Trial of Efficacy of the RetroPerc Device
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of patients with symptom free survival as defined as lack of flank pain
研究概览
简要总结
The purpose of this study is to determine the efficacy of RetroPerc® in obtaining renal access for percutaneous nephrolithotomy
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Renal pelvis and proximal ureteral stones >10 mm confirmed with non-contrast computed tomography
排除标准
- •Suspected pyelonephritis.
- •Prior percutaneous nephrolithotomy procedure in affected kidney.
- •Mid-ureteral or distal ureteral stones.
- •Pregnancy.
- •Anatomical abnormal kidney, including:
- •Horseshoe
研究组 & 干预措施
Treatment (retrograde nephrostomy)
干预措施: retrograde nephrostomy (Device)
Control Group ( antegrade nephrostomy)
干预措施: antegrade nephrostomy (Device)
结局指标
主要结局
Number of patients with symptom free survival as defined as lack of flank pain
时间窗: 6-12 weeks after procedure
Number of patients with symptom free survival as defined as lack of limitations to social or daily activities.
时间窗: 6-12 weeks after procedure
Treatment efficacy as measured by total time of lithotomy operation fluoroscopy
时间窗: (end of procedure)about 3 hours after start of procedure
Treatment efficacy as measured by the time taken from diagnosis to nephrostomy access
时间窗: end of procedure (about 4-8 weeks from diagnosis)
Treatment efficacy as measured by total time of access operation fluoroscopy
时间窗: end of procedure( about 90 minutes after start of procedure)
Treatment efficacy as measured by total time of lithotomy operation
时间窗: end of procedure(about 3 hours after start of procedure)
Treatment efficacy as measured by length of post-operative hospital stay
时间窗: 24 hours after procedure
Number of patients with symptom free survival as defined as lack of presence of urinary or gastrointestinal symptoms,
时间窗: 6-12 weeks after procedure
Number of patients with symptom free survival as defined as lack of limitations to work
时间窗: 6-12 weeks after procedure
Treatment efficacy as measured by total time of access operation.
时间窗: end of procedure( about 90 minutes after start of procedure)
Number of patients that are stone free
时间窗: 6-12 weeks after procedure
stone free is defined as \<2mm on non-contrast computed tomography
次要结局
- Number of patients that require pain medication (defined as discharge with an opioid prescription).(6-12 weeks after procedure)
- Number of patients with nephrostomy access adequate for stone treatment(end of procedure( abut 3 hours from start of procedure))
- Number of patients with normal laboratory values(24 hours after procedure)
- Number of patients with an infection rate which is defined as a positive culture within the study time period(6-12 weeks after procedure)
- Number of patients with normal vital signs(end of procedure( abut 3 hours from start of procedure))
研究者
Nadeem N Dhanani
Assistant Professor
The University of Texas Health Science Center, Houston