Vascular Access Device
Conditions
Brief 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.
Interventions
DEVICECentral 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
Sponsors
Teleflex
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Catheter devices: successful use of the device without removal due to device-related adverse events | 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 | Immediately after subject device removal | Successful verification of catheter tip location |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device-related adverse events | Within 7 days after subject device removal | Incidence of device-related adverse events during placement or use |
| Device-related adverse events within 7 days of device removal | Within 7 days after subject device removal | Incidence of device-related adverse events following removal |
Countries
United States
Contacts
CONTACTSamson Odeyemi
CONTACTMaame E. Sekyere
STUDY_DIRECTORLaura Brinker
Teleflex Incorporated Clinical and Medical Affairs
Outcome results
None listed