NCT01962168已完成不适用
Palliation of Biliary Neoplasms With the Cook Evolution® Biliary Stent System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 9
- 主要终点
- Freedom from symptomatic recurrent biliary obstruction requiring reintervention
研究概览
简要总结
The Evolution® Biliary Stent System Clinical Study is a clinical trial on a commercially available device to gather physician experience with the Cook Evolution® Biliary Stent System for the palliation of cancer in the biliary tree. Patients will be treated as per usual medical practices.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is considered a candidate for stent placement based on institutional guidelines and product IFU.
排除标准
- •Patient is less than 18 years of age.
- •Patient is unable or unwilling to provide written informed consent.
- •Patient is unable or unwilling to comply with the follow-up schedule.
结局指标
主要结局
Freedom from symptomatic recurrent biliary obstruction requiring reintervention
时间窗: 6 months
次要结局
- Technical success(Immediately following completion of the stent placement procedure)
- Incidence of device-related adverse events(6 months)
- Ease of use(Immediately following completion of the stent placement procedure)
研究者
研究点 (9)
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