Evaluation of the Surfacer System Approach to Central Venous Access
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of Participants With Safe Insertion and Patency of Central Venous Access Catheter
研究概览
简要总结
Pre-market Investigational device exemption study evaluating the safety and efficacy of the Surfacer System to facilitate stable upper body central venous access suitable for any conventional catheter.
详细描述
This prospective, single arm, multi-center study is to demonstrate the safety and efficacy of the Surfacer System. Safety will be evaluated based on the overall rate of acute complications using the study device as compared to historical rates of device/procedure related safety events using conventional central venous access methods. Efficacy will be evaluated by the rate of transient successful central venous accesses created by the study device. A total of 30 patients are planned to be enrolled, with 10 patients initially following review of safety data. Duration expected to be through 7 days. A minimum of 3 sites will participate in the study in the United States.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •referred for placement of central venous access catheter
- •have limited or diminishing upper body venous access
- •have pathology impeding standard access methods
- •willing to give written informed consent
排除标准
- •occlusion of the right femoral vein
- •occlusion of the iliac vein
- •occlusion of the inferior vena cava
- •contraindicated by physician
- •acute thrombosis within any vessel planned to be crossed by the Surfacer *tortuous anatomy which precludes a straight line from femoral vein to subclavian
- •diagnosed with active pericarditis
- •diagnosed with active endocarditis
- •suspected pericardial effusion
- •known or suspected aneurysm or ectasia of ascending aorta
- •innominate artery or subclavian artery
- •pregnant or of childbearing potential not taking adequate contraceptive measures or nursing during study
结局指标
主要结局
Number of Participants With Safe Insertion and Patency of Central Venous Access Catheter
时间窗: 7 days
Safety reported as 86.7% (26/30) % of subjects with no procedural complications at discharge through 7 days follow up.
次要结局
- Number of Participants Who Experienced Safe Use of the System to Insert Femoral Vein to Sub-clavicular Exit as Assessed by Central Venous Access Placement in 30 Patients Attempted(7 days)