Surfacer System to Facilitate Access in Venous Occlusions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Absence of all acute safety and device related serious adverse event recorded on case report forms
研究概览
简要总结
Prospective, single-arm, multicentre, international Registry of the Surfacer System for the treatment of patients with limited or diminishing upper body venous access or pathology impeding standard access methods.The purpose of this post-market Registry is to assess the standard of care and clinical outcomes of the Surfacer System used in clinical routine according to the approved commercial indications.
详细描述
This is a prospective, single-arm, multicenter registry of the Surfacer System for patients with limited or diminishing upper body venous access or pathology impeding standard access methods. The need for long term access and lack of availability of veins has led to the development of the Surfacer System, which facilitates reliable and repeatable placement of central venous catheters and restores central venous access. Based on European legislation, this Registry is considered to be an observational study. No additional diagnostic or monitoring procedures as a result of the inclusion are applied to the patients. Available data will be collected in a protected database. Up to 30 patients will be enrolled in 5 sites in Europe. Patients requiring central venous access will be enrolled who meet inclusion and exclusion criteria and for whom the device is indicated.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients referred for placement of a central venous catheter
- •patients with limited or diminishing upper body venous access
- •pathology impeding standard access methods
- •signed informed consent
排除标准
- •vulnerable subjects or incapable of giving consent
- •contraindications to central venous access based on treating physicians opinion or standard of care
- •occlusion of the right femoral vein
- •occlusion of the iliac vein
- •occlusion of the inferior vena
- •acute thrombosis within a vessel (IVC, brachiocephalic and subclavian)
结局指标
主要结局
Absence of all acute safety and device related serious adverse event recorded on case report forms
时间窗: Procedure through discharge at 24 hours post procedure. Data will be presented through study completion, 1 year.
overall complication rate compared to safety data
次要结局
- Surfacer system advancement of the exit wire outside the vein(procedure)
- Ability to place central venous access catheter using Surfacer system(Procedure)
- Insertion of a standard central venous access catheter to deliver fluid or pharmacological agents(procedure)