Use of the PercSys MicroStent Device to Alleviate Ureteral Stone Symptoms and Hydronephrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Relief of hydronephrosis (fluid in kidney causing kidney swelling)
研究概览
简要总结
Kidney stones cause severe pain. Patients with a stone lodged in the ureter (the tube that drains the bladder), require urgent treatment with a stent to relieve the blockage. This tube, or ureteral stent, gives the patient relief until they can have their stone treated. This study is to evaluate a new type of ureteral stent to relieve pain from kidney stones. This stent is designed to drain the kidney and unlike other ureteral stents, is also designed to widen the ureter to help the stone pass on its own.
详细描述
This study is to evaluate a new type of ureteral stent to relieve kidney obstruction from a stone lodged in the ureter. This stent would be placed when a patient presents with pain in the Emergency Room or clinic in a patient that has no signs of infection. It is designed to continue drainage of the kidney and unlike other ureteral stents, is also designed to help dilate the ureter to facilitate spontaneous stone passage. This means the stent may also be therapeutic and the patient would be less likely to undergo another procedure to have the stone removed. Research performed at the Stone Centre at VGH shows that in ex vivo pig kidneys, this stent provides very good urinary drainage of the kidney. This has been published in a peer-reviewed journal (Lange D, Hoag NA, Poh BK, Chew BH. Drainage characteristics of the 3F MicroStent using a novel film occlusion anchoring mechanism. J Endourol. 2011 Jun;25(6):1051-6.).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Perforation of the urinary tract;
- •Acute hemorrhage;
- •Tissue trauma;
- •Submucosal tunneling of guidewire or device during advancement; and
- •Protein encrustation of the device.
排除标准
- •Hemorrhage;
- •Complications associated with the use of anesthesia,
- •Perforation of the urethra or bladder,
- •Scarring or stricture of the urethra; and
- •Urinary retention due to urethral edema.
结局指标
主要结局
Relief of hydronephrosis (fluid in kidney causing kidney swelling)
时间窗: 1-2 weeks following stent placement
Patients will return for radiographic test(s) after the stent placement as determined by the physician which can include kidney-ureter-bladder (KUB) x-ray, renal and bladder ultrasound, or CT scan. This imaging helps determine 2 things: the degree of kidney swelling (hydronephrosis), stent migration and whether their stone is still present or not.
次要结局
- Pain relief(0, 1, 2, 3, 4, 5, 6, 7 post stent placement, and days 1 and 7 post stent removal)
- Migration of stent(1-2 weeks following stent placement)
研究者
Ben Chew, MD
Associate Professor
University of British Columbia