NCT02730663已完成不适用
A Prospective, Multi-center, Single Arm, Non-inferiority, Open-label, Pivotal Study to Evaluate the Effectiveness and Safety of EUS -Guided Transluminal Drainage With 'Niti-S SPAXUS Stent' for the Treatment of Pancreatic Pseudocyst
Taewoong Medical Co., Ltd.12 个研究点 分布在 2 个国家目标入组 36 人开始时间: 2016年3月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 12
- 主要终点
- Number of Participants With Clinical Success
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of endoscopic ultrasound (EUS)-guided transluminal drainage with 'Niti-S SPAXUS Stent' for the treatment of pancreatic pseudocyst.
详细描述
'Niti-S SPAXUS Stent' is a newly designed lumen-apposing fully covered self-expandable metal stent. It is indicated for use in patients with pancreatic pseudocyst. Consecutive subject data should be collected at discharge, stent removal (day 30 or 60), and day 20 post Niti-S SPAXUS stent removal.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pancreatic pseudocyst ≥6cm in size, with ≥70% fluid content that is eligible for transluminal drainage
- •Patient willing to provide written informed consent and comply with follow-up requirements
排除标准
- •Ineligible for endoscopic intervention
- •Pancreatic pseudocyst with severe internal septation
- •Platelet count < 60,000 cells/mm3 or international normalized ratio (INR) >1.5
- •Hemodynamic instability (e.g. shock)
- •Active infectious disease (e.g. endocarditis, meningitis)
- •Participating in any other investigational drug or device clinical trial within past 3 months
- •Female of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant
结局指标
主要结局
Number of Participants With Clinical Success
时间窗: at stent removal (Day 30 or Day 60)
Clinical success is defined as ≥50% decrease in pancreatic pseudocyst size measured on Computed Tomography (CT)
次要结局
- Number of Participants With Procedural/Device Related Serious Adverse Events(up to 90 days (at Day 20 post stent removal))
- Number of Participants With Technical Success(Day 1)
- Number of Participants With Stent Lumen Patency(up to 60 days (at stent removal, Day 30 or 60))
- Other Adverse Events(up to 90 days (at Day 20 post stent removal))
- Number of Participants With Stent Removal Success(up to 60 days (at stent removal, Day 30 or 60))
- Procedure Time(1 day)
研究者
研究点 (12)
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