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
干预措施
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.
研究组 & 干预措施
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System
Experimental
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System
干预措施: HOT AXIOS Stent and Electrocautery- Enhanced Delivery System (Device)
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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