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NCT06604039 | NOT YET RECRUITING | Vascular Access Device

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

Teleflex

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

Condition or disease

Vascular Access Device

Intervention/treatment

Central venous catheter

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 2500 participants
Official Title : A Prospective Clinical Registry Evaluating Safety and Performance of Teleflex Vascular Access Devices
Actual Study Start Date : 2024-12-08
Estimated Primary Completion Date : 2034-12-07
Estimated Study Completion Date : 2034-12-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
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
A Clinical Registry to Demonstrate the Safety and Performance of Teleflex Vascular Access Devices

Location Details

NCT06604039

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

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