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

Teleflex

Status: Not yet enrolling

Conditions: Vascular Access Device

Treatments: Device: Central venous catheter

Study type: Observational

Funder types: Industry

Identifiers

NCT06604039

2024-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,500 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

2,500 participants in 1 patient group

Subject

Description:

Needing a vascular access device for therapy or diagnosis

Treatment:

Device: Central venous catheter