US Post-Market Surveillance Study of the Surfacer* Inside-Out* Access Catheter System (Surfacer System)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 15
- 主要终点
- Incidence of adverse events through 24 hours
研究概览
简要总结
Single arm, observational, multi-center, consecutively enrolling, post-market surveillance study. Treating patients in need of central venous access who have upper body venous occlusions or other conditions that preclude central venous access by conventional methods, and who meet the requirements described in the device labeling.
详细描述
Single arm, observational, multi-center, consecutively enrolling, post-market surveillance study. A minimum of 30 patients will be enrolled in the study, all cases to be performed un-proctored at up to 12 sites in the United States, with no site enrolling more than 6 subjects. All patients enrolled will sign an informed consent form for use of their data. Investigators will invite patients who will be treated with the device in accordance with the approved labeling and who met enrollment criteria to join the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects have been referred for placement of central venous access, i.e., placement of catheter, nutritional line, etc.
- •Subjects with upper body venous occlusions or other conditions that preclude central venous access by conventional methods
- •Subjects are willing and able to give written informed consent
排除标准
- •Occlusion of the right femoral vein, right iliac vein or inferior vena cava
- •Acute thrombus within any vessel to be crossed by Surfacer System (SVC, jugular, IVC, brachiocephalic and subclavian)
- •Occlusion within the arterial system
- •Occlusion within the coronary or cerebral vasculature
结局指标
主要结局
Incidence of adverse events through 24 hours
时间窗: 24 hours
no procedural adverse events or peri procedural adverse events
Central Venous Access operational
时间窗: 24 hours
safe insertion of the device to facilitate central venous access
次要结局
未报告次要终点