NCT01343160已完成不适用
Multicenter Study of Removable GORE VIABIL® Biliary Endoprosthesis for Treatment of Benign Biliary Strictures
W.L.Gore & Associates1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2011年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Safe Stent Removal
研究概览
简要总结
The purpose of this study is to generate clinical data to support the use of GORE® VIABIL® Biliary Endoprosthesis in the endoscopic and percutaneous treatment of benign biliary strictures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 否
入选标准
- •Subject is diagnosed with treatable benign biliary stricture which necessitates the need for implantation of a biliary endoprosthesis
- •Subject is ≥18 years of age
- •Subject is able to comply with study protocol and follow-up requirements
- •Written informed consent is obtained using the Investigational Review Board (IRB)/Ethics Committee (EC) approved consent form
排除标准
- •Subject anatomy ruling out covered self expanding metal stent use (e.g. above hilar region)
- •Treatment of stricture would require placement of a covered biliary endoprosthesis within a previously placed bare metal stent
- •The subject has malignant biliary disease
- •Subject has known pregnancy
- •Participated in protocol involving investigational drug or device within 90 days prior to entry into this study
研究组 & 干预措施
GORE VIABIL® Biliary Endoprosthesis
Other
Placement of GORE VIABIL® Biliary Endoprosthesis to establish duct patency
干预措施: GORE® VIABIL® Biliary Endoprosthesis (Device)
结局指标
主要结局
Safe Stent Removal
时间窗: Upon Removal
The stent removal is considered safe when the Study Device is removed successfully and without SAEs.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
暂停
不适用
GORE® VIABIL® Biliary Endoprosthesis in the Treatment of Benign Biliary Strictures Secondary to Chronic PancreatitisBile Duct StricturePancreatitis, ChronicNCT05820009W.L.Gore & Associates133
已完成
不适用
Prospective Evaluation of Biliary Tissue Sampling With ERCPCholangiocarcinomaBiliary Tract DiseasesCholangiopancreatography, Endoscopic RetrogradeBiliary StrictureNCT04572711Mayo Clinic327
已完成
不适用
Archimedes Bio-degradable Bile Duct Stent StudyBile LeakCommon Bile Duct Stone With Chronic CholecystitisNCT04477005Nottingham University Hospitals NHS Trust64
终止
不适用
Study of the Braive Growth Modulation System for Progressive Pediatric ScoliosisJuvenile Idiopathic ScoliosisAdolescent Idiopathic ScoliosisNCT04929678Medtronic Spinal and Biologics10
已完成
不适用
Clinical Outcomes Associated With the Use of ViviGen® for the Treatment of Lumbar Degenerative Disc DiseaseLumbar RadiculopathyDegenerative Disc DiseaseLumbar SpondylolisthesisLumbar Disc DiseaseDegenerative SpondylolisthesisLumbar Spinal StenosisNCT03733626Corewell Health East46