A Clinical Registry to Demonstrate the Safety and Performance of Teleflex Vascular Access Devices
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Central venous catheter.
- Who it may be relevant to
- Registry conditions: Vascular Access Device. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Clinical Registry Evaluating Safety and Performance of Teleflex Vascular Access Devices
Overview
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
- 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
Primary outcome measures
- Catheter devices: successful use of the device without removal due to device-related adverse events [Time frame: Within 7 days after subject device removal]
- Arrow VPS Rhythm DXL catheter tip positioning system: Successful verification of catheter tip location [Time frame: Immediately after subject device removal]
Secondary outcome measures (2)
- Device-related adverse events [Time frame: Within 7 days after subject device removal]
- Device-related adverse events within 7 days of device removal [Time frame: Within 7 days after subject device removal]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 3 centers
- Huntsville Hospital — Huntsville
- Loma Linda University Health — Loma Linda
- Tufts Medical Center — Boston
Identifiers
NCT: NCT06604039 · 2024-02