The RELIEF™ Ureteral Stent - Assessment of Retrograde Urinary Reflux
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 50
- 主要终点
- Retrograde urine reflux
研究概览
简要总结
Assessment of the backwards flow of urine from the bladder into the ureter (retrograde urine reflux) after placement of the RELIEF® Ureteral Stent using imaging of the bladder after filling it with contrast and assigning a urinary reflux grade. Randomized controlled trial for evaluation of the stent placement and the adequacy of short term drainage (defined as the presence of the stent in the ureter and the lack of surgical or standard of care double J stent to treat symptoms associated with the stent itself on the stented side during the first 48 hours).
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Has capacity to consent
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Persons, 18 years of age or older
- •Male or female subjects with confirmed ureteral and/or renal stones or strictures documented via abdomen X-ray KUB (kidney ureter bladder) or CT (computed tomography)
排除标准
- •Distal ureteral obstruction where suture portion of stent may be placed
- •Urinary reflux (assessed by pre-stent cystogram)
- •Pregnancy or lactation
- •Patients requiring bilateral surgical stone management procedure
- •Infected stones
- •Patients where 24cm or 26cm stent lengths are not suitable
- •Ureteral structure in distal third of ureter
- •Intraoperative exclusion: based on urologist's discretion, if trauma has been induced to the distal ureter due to ureteroscopy maneuvers, exclude these patients
研究组 & 干预措施
Standard of Care Ureteral Stent
干预措施: Standard of Care Ureteral Stent (Device)
RELIEF Ureteral Stent
干预措施: RELIEF Ureteral Stent (Device)
结局指标
主要结局
Retrograde urine reflux
时间窗: At time of stent placement - Day 0, and through study completion - an average of 12 weeks post-operatively
Assessment of retrograde urine reflux after placement of a ureteral stent using cystography after contrast gravity-filling of the bladder and assigning a urinary reflux grade based on standard scoring.
次要结局
- Stent symptoms(Up until stent removal - Day 7-14, and through study completion - and average of 12 weeks post-operatively)
研究者
Seth Bechis
Associate Professor of Urology
University of California, San Diego