NCT05820009暂停不适用
Evaluation of the GORE® VIABIL® Biliary Endoprosthesis in the Treatment of Benign Biliary Strictures Secondary to Chronic Pancreatitis
W.L.Gore & Associates2 个研究点 分布在 1 个国家目标入组 133 人开始时间: 2024年2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
- 暂停
- 发起方
- 入组人数
- 133
- 试验地点
- 2
- 主要终点
- Safe stent removal as reported by serious adverse event reporting
研究概览
简要总结
This study will evaluate the safety and effectiveness of the GORE® VIABIL® Biliary Endoprosthesis in the treatment of benign biliary strictures secondary to Chronic Pancreatitis (CP).
详细描述
A maximum of 15 clinical investigative sites across the U.S. will participate in this study. One hundred and thirty-three subjects are intended to be implanted with the GORE® VIABIL® Biliary Endoprosthesis in this study. Subjects will be evaluated at the time of device placement and will have follow-up visits at 1 week and 1, 3, 6, and 9 months during indwell; subjects will have the device removed at 10-12 months and have post removal follow-up visits at 1 week and 1, 3, 6, 12 and 24 months.
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
- •A diagnosis of chronic pancreatitis
- •Indication for ERCP with FCSEMS placement determined by one or more of the following:
- •Presence of a Bismuth type I BBS confirmed by imaging (e.g., cholangiography, Computed Tomography [CT], Magnetic Resonance Cholangiopancreatography [MRCP], etc.) collected ≤ 60 days prior to the index procedure and an elevation of serum alkaline phosphatase (>2 times the upper limit of institutional reference range)
- •Presence of a symptomatic (e.g., jaundice, cholangitis, and/or choledocholithiasis) Bismuth type I BBS confirmed by imaging (e.g., cholangiography, CT, MRCP, etc.) collected ≤ 60 days prior to the index procedure with an elevation of serum alkaline phosphatase (>2 times the upper limit of institutional reference range)
- •A planned exchange of multiple side-by-side plastic stents (whose combined diameters are ≤ 20 Fr) that were previously placed for management of a Bismuth type I BBS secondary to chronic pancreatitis
- •Underlying stricture malignancy has been reasonably excluded (e.g., by any of the following techniques - biopsy, Endoscopic Ultrasound [EUS], Computed Tomography [CT], or Magnetic Resonance Imaging [MRI] with or without Magnetic Resonance Cholangiopancreatography [MRCP]) ≤ 60 days prior to index procedure
- •≥ 18 years old at the time of informed consent signature
- •Male, infertile female, or woman of childbearing potential with a negative beta Human Chorionic Gonadotropin (hCG) pregnancy test within 7 days of the index procedure
- •Able and willing to provide written informed consent (or has a Legally Authorized Representative) to participate in the study prior to any study procedures
- •Willing and able to comply with the study procedures and follow-up requirements
排除标准
- •Concurrent participation in another interventional study that involves an investigational product being introduced to the body
- •A contraindication for endoscopic techniques
- •Life expectancy < 2 years
- •A history of malignant biliary or malignant pancreatic disease
- •Prior or existing biliary self-expanding metal stent (SEMS)
- •Prior or planned exchange of multiple side-by-side plastic stents whose combined diameters are greater than 20 Fr
- •Development of obstructive biliary symptoms associated with a present attack of acute pancreatitis
- •Any biliary stricture etiology other than chronic pancreatitis
- •Other therapeutic endoscopic procedures performed during the index or removal procedure that are not associated with bile duct stricture secondary to Chronic Pancreatitis including but not limited to planned Fine Needle Aspiration (FNA) or Fine Needle Biopsy (FNB) of the pancreas
- •Concomitant Bismuth type II-IV stricture
- •Inability for the guidewire to traverse the papillae and the stricture (e.g., as a result of surgically altered anatomy)
- •Inability to pass the endoscope to the papillae without the need for mechanical dilation
- •Known bile duct fistula or leak
- •Biliary stricture length > 100 mm (10 cm)
研究组 & 干预措施
GORE® VIABIL® Biliary Endoprosthesis
Experimental
GORE® VIABIL® Biliary Endoprosthesis
干预措施: GORE® VIABIL® Biliary Endoprosthesis (Device)
GORE® VIABIL® Biliary Endoprosthesis
Experimental
GORE® VIABIL® Biliary Endoprosthesis
干预措施: GORE® VIABIL® Short Wire Biliary Endoprosthesis (Device)
结局指标
主要结局
Safe stent removal as reported by serious adverse event reporting
时间窗: At removal (10-12 months)
Ability to remove the Study Device endoscopically without stent removal-related serious adverse events (SAEs) as assessed from the time of Study Device removal to one month (30 days) post-Study Device removal.
次要结局
- Placement success as determined by imaging(Day 0)
- Removal success as determined by imaging(At removal (10-12 months))
- Stricture resolution at stent removal as determined by imaging(At removal (10-12 months))
- Stent functionality as determined by adverse event reporting(During indwell up to 12 months)
- Migration as determined by imaging(During indwell up to 12 months)
- Stricture recurrence as determined by adverse event reporting(From removal up to 24 months)
- Device- or procedure-related SAEs as determined by serious adverse event reporting(Day 0-13 months (including through 30 days post-removal))
- Liver Function as determined by alkaline phosphatase, alanine aminotransferase, and aspartate aminotransferase levels(Baseline, indwell follow-up visits (up to 12 months), at removal (10-12 months), and post-removal follow up visits (up to 24 months))
- Liver Function as determined by direct bilirubin, and total bilirubin(Baseline, indwell follow-up visits (up to 12 months), at removal (10-12 months), and post-removal follow up visits (up to 24 months))
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Removable GORE VIABIL® Biliary Endoprosthesis for Treatment of Benign Biliary StricturesBiliary StricturesNCT01343160W.L.Gore & Associates43
已完成
不适用
GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study (JPS 16-03)Peripheral Arterial DiseaseNCT04706273W.L.Gore & Associates321
已完成
不适用
GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance StudyVascular Stent-Graft StenosisNCT04429243W.L.Gore & Associates124
已完成
3 期
GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in HemodialysisRenal FailureHemodialysisNCT00737672W.L.Gore & Associates293
已完成
不适用
Evaluation of the GORE® VIABAHN® Endoprosthesis for the Treatment of Popliteal Artery Aneurysm (PAA)Popliteal Artery AneurysmNCT02462876W.L.Gore & Associates60