A Multi-Center, Single Arm, Prospective Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 6
- 主要终点
- Number of Participants With Absence of Recurrent Biliary Obstruction
研究概览
简要总结
This is a a prospective study of the WallFlex™ Biliary Partially-covered Stent designed to collect data to support regulatory clearance by the FDA in the United States and to determine the functionality of the WallFlex™ Biliary Partially Covered Stent as a Palliative treatment for malignant bile duct obstruction.
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 years or older
- •Inoperable extrahepatic biliary obstruction by any malignant process
- •Indicated for metal stent placement for palliative treatment of biliary stricture(s) produced by malignant neoplasms
- •Willing and able to comply with the study procedures and provide written informed consent to participate in the study
排除标准
- •Participation in another invesitgational study within 90 days prior to date of patient consent.
- •Strictures that cannot be dialated enough to pass the delivery system
- •Perforation of any duct within the biliary tree
- •Presence of any esophageal or duodenal stent
- •Patients for whom endoscopic procedures are contraindicated
- •Patients with known senesitivity to any components of the stent or delivery system
- •Patients with active hepatitis
研究组 & 干预措施
WallFlex Stent
All patients meeting eligibility criteria recieve the WallFlex™ Biliary Partially-Covered Stent, which has regulatory clearance in the areas in which the study is being conducted.
干预措施: WallFlex™ Biliary Partially-Covered Stent (Device)
结局指标
主要结局
Number of Participants With Absence of Recurrent Biliary Obstruction
时间窗: Up to 6 months post treatment or prior to death, whichever came first
Defined as absence of recurrent biliary obstruction defined as absence of biliary symptoms. Biliary symptoms, included, but were not limited to jaundice, itching, right upper quadrant abdominal pain, nausea, vomiting, fever, and dark urine. Symptom assessment occurred during the Screening/Baseline period and at all follow-up time points.
次要结局
- Change in Biliary Obstruction Symptoms(up to 6 months post-initial study treatment)
- Time to Recurrent Biliary Obstruction(Up to 6 months)
- Change in Bilirubin(1 month following stent placement)
- Number of Participants With Technical Stent Placement Success(Initial stent placement procedure)
- Number of Participants With Occurrence of Re-intervention(Up to 6 months post-initial study treatment)
- Number of Adverse Events Related to the Device and/or Procedure(From time participant signs informed consent until time participant exits study (up to 6 months following stent placement))