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NCT Number: NCT06604039

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

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

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Huntsville Hospital, Huntsville, Alabama, United States

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Central Venous Catheter

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

Other names: Peripherally inserted central catheter, Dialysis catheter, Midline intravenous catheter, Peripheral intravenous catheter, Arterial catheter, Catheter navigation/tip confirmation device

Primary outcomes

  1. Catheter devices: successful use of the device without removal due to device-related adverse events

    Time frame: Within 7 days after subject device removal

    The proportion of device uses successfully completed without device removal due to device-related adverse events

  2. Arrow VPS Rhythm DXL catheter tip positioning system: Successful verification of catheter tip location

    Time frame: Immediately after subject device removal

    Successful verification of catheter tip location

Secondary outcomes

  1. Device-related adverse events

    Time frame: Within 7 days after subject device removal

    Incidence of device-related adverse events during placement or use

  2. Device-related adverse events within 7 days of device removal

    Time frame: Within 7 days after subject device removal

    Incidence of device-related adverse events following removal

Other outcomes

  1. Adverse event caused by use of device accessory

    Time frame: Within 7 days after subject device removal

    Clinicians used accessory safely

  2. Device accessory used successfully

    Time frame: Within 7 days after subject device removal

    Clinician used accessory successfully

  3. Duration of use

    Time frame: Within 7 days after subject device removal

    How long the device was in use for the patient

  4. Usability score

    Time frame: Within 7 days after subject device removal

    Subject device usability score. Medical Device Usability Score: Scale of 1-5 in which 1=very difficult, 2=difficult, 3=acceptable, 4=easy, 5=very easy

Study contacts

Contact information is provided by the study sponsor or research team.

Aderinola (Derin) Ogundimu, PhD, ACRP, PMP

CONTACT

[email protected]

469.569.9223

Thomas E. Philbeck, Jr., PhD

CONTACT

[email protected]

2107227438

Sponsors and collaborators

Lead sponsor

Teleflex

Industry

Registry information

Official study title

A Prospective Clinical Registry Evaluating Safety and Performance of Teleflex Vascular Access Devices

Acronym: VADER

Important dates

Study start
2024
Primary completion
2034
Study completion
2034
First posted
Sep 19, 2024
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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