NCT02104076已完成不适用
Evaluation for the Effectiveness of Evolution® Biliary Stent System-Fully Covered
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 12
- 主要终点
- Percentage of patients free from symptomatic recurrent of biliary obstruction requiring reintervention
研究概览
简要总结
The Evolution® Biliary Stent System-Fully Covered study is a clinical trial approved by the US FDA to evaluate the effectiveness of the Evolution® Biliary Stent System-Fully Covered when used in palliation of malignant neoplasms in the biliary tree.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •Inoperable malignant neoplasm causing biliary obstruction or stricture that requires a fully covered metal stent
排除标准
- •< 18 years of age
- •Unwilling or unable to sign and date the informed consent
- •Unwilling or unable to comply with the follow-up schedule
- •Undergone or is planning to undergo brachytherapy with transpapillary or percutaneous implantation of intracavitary radiation sources
- •Participating in another investigational drug or device study in which patient has not completed the follow-up phase for the primary endpoint at least 30 days prior to enrollment
- •Endoscopic procedures are contraindicated
- •Current anatomy upstream of intended stent placement compromising the flow of bile from the liver such that stent placement may not alleviate the biliary obstruction symptoms
- •Presence of a metal biliary stent
- •Presence of an esophageal or duodenal stent
- •Hypersensitivity/allergy or contraindication to any component of the stent, delivery system, or medication required to complete the procedure,which in the investigator's opinion cannot be adequately premedicated
- •Coagulopathy
- •Diffuse intrahepatic metastases that involves > 10 % of the liver
- •Life expectancy of < 3 months
- •Active alcohol or substance abuse issue
- •Jaundice secondary to a cause other than biliary duct obstruction
- •Additional endoscopic restrictions as specified in the Clinical Investigation Plan
研究组 & 干预措施
Evolution® Biliary Stent-Fully Covered
Experimental
干预措施: Evolution® Biliary Stent-Fully Covered (Device)
结局指标
主要结局
Percentage of patients free from symptomatic recurrent of biliary obstruction requiring reintervention
时间窗: 6 months
Total Serum Bilirubin ≤ 3.0 mg/dL
时间窗: 1 month
次要结局
未报告次要终点
研究者
研究点 (12)
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