NCT02007980Unknown不适用
Examining the Underlying Factors That Cause Ureteral Stent Discoloration in Japanese and Canadian Ureteral Stents
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- stent encrustation
研究概览
简要总结
The aim of this study is to identify the root cause for the significant discolouration of Boston Scientific Percuflex based stents.
详细描述
The aim of this study is to identify the root cause for the significant discolouration of Boston Scientific Percuflex based stents observed in some patients, particularly those from Japan. We will also test and compare them to stents from Canadian patients. Furthermore, we will determine whether the discolouration promotes bacterial adhesion and/or encrustation of the stent.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 是
入选标准
- •Patient is at least 19 years of age (Vancouver, British Columbia, Canada - for Japan different age limit as applicable)
- •Patient has indwelling ureteral stent
排除标准
- •Pregnancy
- •Positive Urine Culture
- •Active cancer
- •Recurrent urinary infections
- •Gross hematuria
- •Inability to provide informed consent
- •Physician/Surgeon refuses to enter patient into study
结局指标
主要结局
stent encrustation
时间窗: at stent removal
Conditioning film components and encrustation
次要结局
- characterize the components that discolour the Percuflex material(bench top testing of stents)
- Bacterial Adhesion, Colonization, and Biofilm formation(at 4, 24, and 48 hours post stent removal)
研究者
Ben Chew, MD
Associate Professor
University of British Columbia
研究点 (1)
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