A Non-Randomized, Multi-Center, Prospective, Single Arm Clinical Study of the X-SUIT NIR® Covered Biliary Metallic Stent for Palliation of Malignant Strictures in the Biliary Tree Via Endoscopic Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Medinol Ltd.
- 入组人数
- 68
- 试验地点
- 18
- 主要终点
- Maintenance of a total serum bilirubin level ≤ 3.0 mg/dL or a reduction of >30% if baseline value was greater than 3.0 mg/dL
研究概览
简要总结
The purpose of this study is to provide safety and efficacy data for the X-Suit NIR® Covered Biliary Metallic Stent for subjects with malignant stricture(s) in the biliary tree. The study is designed to support the regulatory requirement of a 510(k) marketing application in the United States.
详细描述
This is a non-randomized, multi-center, prospective, single arm clinical study of the X-Suit NIR® Covered Biliary Metallic Stent for the palliation of malignant strictures in the biliary tree via endoscopic approach.
Adult males and females (≥ 18 years old), with clinical symptoms of biliary obstruction and inoperable extrahepatic biliary obstruction by any malignant process.
The expected duration of this study is approximately 18 months from the time of first subject enrollment to the time of the last subject's 6-month post stent implantation follow-up visit.
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
- •Age 18 or older.
- •Clinical symptoms of biliary obstruction.
- •Presence of inoperable extrahepatic distal biliary obstruction by any malignant process (the subject not being a surgical candidate based on the finding of a pancreatic mass >2.0cm or a severe medical illness).
- •Subject is willing and able to comply with the study procedures and provide written informed consent to participate in the study.
- •Insured by Social Security (applicable to subjects screened in France).
排除标准
- •Participation in an Investigational Study within 90 days prior to date of subject consent.
- •Perforation of any duct within the biliary tree.
- •Presence of more than one previously implanted plastic stent.
- •Previous plastic stent implantation less than 2 weeks prior to current procedure.
- •Presence of a metal biliary stent.
- •Presence of any esophageal or duodenal stent.
- •Previous Bilroth II or Roux-en-Y gastric resection, a significant duodenal obstruction or any other altered anatomy which could prevent access to ampulla.
- •Subjects for whom endoscopic procedures are contraindicated.
- •Subjects with known sensitivity to any components of the stent or delivery system.
- •Subjects with active hepatitis or other hepatic diseases that may cause jaundice.
- •Subjects with a WHO performance score of 4 - Bedbound (completely disabled, cannot carry on any self-care, totally confined to bed or chair).
- •Subjects known to be pregnant.
- •Cholangiographic exclusion criterion:
- •Strictures that cannot be passed by the guide wire or the delivery system.
结局指标
主要结局
Maintenance of a total serum bilirubin level ≤ 3.0 mg/dL or a reduction of >30% if baseline value was greater than 3.0 mg/dL
时间窗: 6 months follow up or prior to death, whichever comes first
Maintenance of a total serum bilirubin level ≤ 3.0 mg/dL or a reduction of \>30% if baseline value was greater than 3.0 mg/dL- outcome
次要结局
- total number of adverse events(6 months)