A Prospective, Multi-center, Non-blinded, Single-arm (Nonrandomized) Study of the AXIOS Stent and Delivery System

Xlumena, Inc.13 个研究点分布在 2 个国家目标入组 30 人开始时间: 2011年8月最近更新: 2015年9月21日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Xlumena, Inc.
入组人数: 30
试验地点: 13
主要终点: Safety - Freedom From Major Complications: Access Site-related Bleeding

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The Xlumena AXIOS Stent and Delivery System is an investigational device in the USA, and this study is being conducted under an Investigational Device Exemption (IDE) granted by the US Food and Drug Administration (FDA).

The study design is prospective, multi-center, non-blinded, single-arm (nonrandomized) study. Up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.

Patients will be followed at (approximately) 30 days and/or 60 days depending upon pseudocyst resolution confirmation, at 1-week post-stent removal,and possibly at 3 and 6 month post-stent removal.

详细描述

OBJECTIVE:

To demonstrate the safety and effectiveness of the Xlumena AXIOS Stent and Delivery System for endoscopic drainage of pancreatic pseudocysts in patients with symptomatic pancreatic pseudocysts that are greater than or equal to 6 cm (≥6cm) in diameter, have ≥ 70% fluid contents and are adherent to the bowel wall.

STUDY DESIGN:

Prospective, multi-center, non-blinded, single-arm (nonrandomized) study

KEY ENDPOINTS:

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

•(patients must meet all criteria)
•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 than or equal to 6 cm in size (based upon the maximum crosssectional area in the CT scan),
•Adherent to bowel wall, and
•≥70% fluid content
•Patient understands the study requirements and the treatment procedures and provides written Informed Consent using a form that has been approved by the local Institutional Review Board or Ethics Committee before any study-specific tests or procedures are performed.
•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

•(patients meeting any of the below criteria will be excluded from study)
•<18 or >75 years of age
•Pancreatic pseudocysts having the following characteristics:
•Require nasocystic drainage,
•< 69% 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.