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

A Prospective Clinical Registry Evaluating 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

Study Overview

• Status: Recruiting
• Conditions: Vascular Access Device
• Intervention / Treatment: Device: 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
• Enrollment (Estimated): 2500

Contacts and Locations

• Study Contact: Name: Aderinola (Derin) Ogundimu, PhD, ACRP, PMP; Phone Number: 469.569.9223; Email: aderinola.ogundimu@teleflex.com
• Study Contact Backup: Name: Thomas E. Philbeck, Jr., PhD; Phone Number: 2107227438; Email: thomas.philbeck@teleflex.com

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Recruiting
      • Huntsville Hospital
      • Contact: Sara Couey, DNP, CRNP; Email: sara.couey@hhsys.org
  • California
    • Loma Linda, California, United States, 92354
      • Recruiting
      • Loma Linda University Health
      • Contact: Melissa McCabe, MD, MSCR; Email: mmccabe@llu.edu
      • Contact: Sarah Capalla, MSN, RN; Email: scapalla@llu.edu
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Recruiting
      • Tufts Medical Center
      • Contact: Haval Chweich, MD; Email: haval.chweich1@tuftsmedicine.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Subjects who are scheduled to receive a vascular access procedure using at least one Teleflex vascular access device will be considered for enrollment.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Subject; Needing a vascular access device for therapy or diagnosis

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Catheter devices: successful use of the device without removal due to device-related adverse events	The proportion of device uses successfully completed without device removal due to device-related adverse events	Within 7 days after subject device removal
Arrow VPS Rhythm DXL catheter tip positioning system: Successful verification of catheter tip location	Successful verification of catheter tip location	Immediately after subject device removal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device-related adverse events	Incidence of device-related adverse events during placement or use	Within 7 days after subject device removal
Device-related adverse events within 7 days of device removal	Incidence of device-related adverse events following removal	Within 7 days after subject device removal

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event caused by use of device accessory	Clinicians used accessory safely	Within 7 days after subject device removal
Device accessory used successfully	Clinician used accessory successfully	Within 7 days after subject device removal
Duration of use	How long the device was in use for the patient	Within 7 days after subject device removal
Usability score	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	Within 7 days after subject device removal

Collaborators and Investigators

• Sponsor: Teleflex
• Investigators: Study Director: Amy Bardin, Teleflex Incorporated Clinical and Medical Affairs

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2024
• Primary Completion (Estimated): December 7, 2034
• Study Completion (Estimated): December 7, 2034

Study Registration Dates

• First Submitted: August 8, 2024
• First Submitted That Met QC Criteria: September 16, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: August 1, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2024-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Undecided at this time

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No