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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-08

Study Completion Date

2034-12-07

Brief Summary

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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

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Detailed Description

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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

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Vascular Access Device

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Subject

Needing a vascular access device for therapy or diagnosis

Central venous catheter

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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Peripherally inserted central catheter Dialysis catheter Midline intravenous catheter Peripheral intravenous catheter Arterial catheter Catheter navigation/tip confirmation device

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No