AXIOS Stent With Electrocautery Enhanced Delivery System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 16
- 主要终点
- Safety/Adverse Event Outcome Measure 3
研究概览
简要总结
The purpose of this study is to demonstrate the safety and effectiveness of the AXIOS Stent with Electrocautery Enhanced Delivery System for endoscopic transenteric drainage of pancreatic pseudocysts.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years old, male or female
- •Eligible for endoscopic intervention
- •Acceptable candidate for endoscopic transluminal pancreatic pseudocyst drainage
- •Symptomatic pancreatic pseudocyst having the following characteristics:
- •Greater or equal to 6 cm in diameter (based upon the maximum cross-sectional area in the CT scan or transabdominal ultrasound).
- •Adherent to bowel wall, and
- •≥70% fluid content
- •Patient understands the study requirements and the treatment procedures and provides written Informed Consent.
- •Patient is willing to comply with all specified follow-up evaluations, including willingness to undergo a pre/post CT imaging study.
排除标准
- •The fluid collection to be drained is an immature pseudocyst
- •The fluid collection to be drained is a cystic neoplasm
- •The fluid collection to be drained is a pseudoaneurysm
- •The fluid collection to be drained is a duplication cyst
- •The fluid collection to be drained is a non-inflammatory fluid collection
- •There is more than one pseudocyst requiring drainage
- •Abnormal coagulation:
- •INR > 1.5 and not correctable
- •presence of a bleeding disorder
- •platelets < 50,000/mm3
- •Altered anatomy that precludes the physician's ability to deliver the stent (decision on a case by case basis).
- •Intervening gastric varices or vessels within a one centimeter radius of the needle (visible using endoscopy or endoscopic ultrasound)
- •Any prior true anaphylactic reaction to contrast agents, nitinol (nickel titanium), silicone or any other materials contacting the patient.
- •Female of childbearing potential with a positive pregnancy test prior to the procedure or intends to become pregnant during the study.
- •Currently participating in another investigational drug of device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
结局指标
主要结局
Safety/Adverse Event Outcome Measure 3
时间窗: Index procedure through 1-week post-stent removal
Freedom from surgery for access-site related perforation
Safety/Adverse Event Outcome Measure 2
时间窗: Index procedure through 1-week post-stent removal
Freedom from access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization
Safety/Adverse Event Outcome Measure 6
时间窗: Index procedure through 1-week post-stent removal
Freedom from serious adverse event associated with the AXIOS stent and/or (index) implant procedure
Safety/Adverse Event Outcome Measure 5
时间窗: Index procedure through 1-week post-stent removal
Freedom from tissue injury, defined as ulceration at site of stent implant as observed to persist through 1-week post-stent removal
Safety/Adverse Event Outcome Measure 1
时间窗: Index procedure through 1-week post-stent removal
Freedom from access site-related bleeding requiring transfusion
Safety/Adverse Event Outcome 4
时间窗: Index procedure through 1-week post-stent removal
Freedom from stent migration/dislodgement into the pseudocyst or enteral lumen
次要结局
- Technical Success Outcome Measure 1(Index Procedure)
- Technical Success Outcome Measure 2(30 or 60 Day Post-procedure)
- Stent Retention Outcome Measure(30 or 60 days post-procedure)
- Lumen Patency Outcome Measure(30 and/or 60 days post-procedure)
- Clinical Success Outcome Measure(30 or 60 days post-procedure)