NCT03808272已完成不适用
A Prospective, Multi-center, Single-arm Study to Evaluate the Safety and Efficacy of AXIOS Stent and Electrocautery-enhanced Delivery System in Chinese Patients With Pancreatic Pseudocyst and Walled-off Necrosis(WON)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Technical success rate
研究概览
简要总结
To study the safety and effectiveness of the AXIOS Stent with Electrocautery Enhanced Delivery System for endoscopic trans enteric drainage of pancreatic pseudocyst and walled-off necrosis in Chinese population, to support the regulatory approval by CFDA
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(including 18 and 75 years old)
- •Eligible for endoscopic intervention
- •Acceptable candidate for endoscopic transluminal pancreatic pseudocyst drainage
- •Diagnostic as symptomatic pancreatic pseudocysts ≥ 6cm in maximum diameter and walled-off necrosis ≥ 6cm in maximum diameter with ≥ 70% fluid content that are adherent to the gastric or bowel wall
- •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
- •<18 or >75 years of age
- •pseudocysts or walled-off necrosis which require nasocystic drainage,or<6cm in maximum diameter, or walled-off necrosis < 70% fluid content
- •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
Technical success rate
时间窗: 28± 7 days post stent placement
defined as: placement of the AXIOS stent using the Electrocautery Enhanced AXIOS delivery system and removal of the AXIOS stent using a standard method: such as endoscopic snare or forceps.
Clinical success rate
时间窗: 28± 7 days post stent placement
defined as: at least a 50% decrease in pseudocyst's maximum diameter, based on radiographic analysis
次要结局
未报告次要终点
研究者
研究点 (1)
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