NCT06604039

A Clinical Registry to Demonstrate the Safety and Performance of Teleflex Vascular Access Devices

A Prospective Clinical Registry Evaluating Safety and Performance of Teleflex Vascular Access Devices

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,500 (estimated)
• Sponsor: Teleflex · Industry
• Sex: All
• Age: —
• Healthy volunteers: —

Summary

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

Detailed description

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.

Conditions

• Vascular Access Device

Interventions

Type	Name	Description
DEVICE	Central venous catheter	Placement of a medical device to gain entry into the bloodstream, typically through a vein or artery, for the purpose of administering fluids, medications, blood products, or for hemodialysis

Timeline

• Start date: 2024-12-08
• Primary completion: 2034-12-07
• Completion: 2034-12-07
• First posted: 2024-09-19
• Last updated: 2025-08-07

Locations

3 sites across 1 country: United States