A Prospective Clinical Registry Evaluating Safety and Performance of Teleflex Vascular Access Devices
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Teleflex
- 入组人数
- 2,500
- 试验地点
- 5
- 主要终点
- Catheter devices: successful use of the device without removal due to device-related adverse events
研究概览
简要总结
The general objective of Teleflex's Vascular Access Device Registry (VADER) is to provide high-quality Level 3 (or better) data on the performance, safety and clinical benefits of Teleflex's vascular access devices when used in a real-world setting
详细描述
The primary objective is to provide high-quality Level 3 (or better), data as defined by Medical Device Coordination group (MDCG) 2020-6, on the performance, and clinical benefits of Teleflex's vascular access devices when used in a real-world setting. The hypothesis is that, when used in accordance with the instructions for use (IFU), the vascular access devices will perform safely and successfully.
The Teleflex vascular access devices (index devices and accessories) in scope for this Registry vary in type from central venous access devices (CVAD) to midline catheters to peripheral catheters to hemodialysis catheters to arterial catheters navigation/tip confirmation devices. Many, but not all, of the devices also have antimicrobial and antithrombogenic properties. Also in scope are the accessories routinely used for placement and maintenance of the index devices.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will undergo a procedure that will include use of a Teleflex device covered by this Research.
- •Subject is willing and capable of providing informed consent and/or give approval to collect, store and process limited health information by the Sponsor; or such consent is provided by a legally designated representative if required by local law or regulation.
- •Subjects is able to read and understand English or Spanish languages
排除标准
- •Subject is currently participating in another clinical Registry or investigation that may confound the results of this Registry.
- •Subject was previously failed screening or was enrolled in this clinical Registry.
- •Subject is imprisoned
- •Subject is cognitively impaired and unable to provide informed consent
研究组 & 干预措施
Subject
Needing a vascular access device for therapy or diagnosis
干预措施: Central venous catheter (Device)
结局指标
主要结局
Catheter devices: successful use of the device without removal due to device-related adverse events
时间窗: Within 7 days after subject device removal
The proportion of device uses successfully completed without device removal due to device-related adverse events
Arrow VPS Rhythm DXL catheter tip positioning system: Successful verification of catheter tip location
时间窗: Immediately after subject device removal
Successful verification of catheter tip location
次要结局
- Device-related adverse events(Within 7 days after subject device removal)
- Device-related adverse events within 7 days of device removal(Within 7 days after subject device removal)