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

NCT06604039 | Recruiting

• 1 other identifier: 2024-02
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 3

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

Conditions

Vascular Access Device

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Device-related adverse events

  Within 7 days after subject device removal

• Device-related adverse events within 7 days of device removal

  Within 7 days after subject device removal

Other Outcomes (4)

• Adverse event caused by use of device accessory

  Within 7 days after subject device removal

• Device accessory used successfully

  Within 7 days after subject device removal

• Duration of use

  Within 7 days after subject device removal

Study Arms (1)

Subject

Needing a vascular access device for therapy or diagnosis

Device: Central venous catheter

Interventions

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

Also known as: Peripherally inserted central catheter, Dialysis catheter, Midline intravenous catheter, Peripheral intravenous catheter, Arterial catheter, Catheter navigation/tip confirmation device

Subject

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Teleflex: lead

Study Sites (3)

Huntsville Hospital

Huntsville, Alabama, 35801, United States

RECRUITING

Loma Linda University Health

Loma Linda, California, 92354, United States

RECRUITING

Tufts Medical Center

Boston, Massachusetts, 02111, United States

RECRUITING

MeSH Terms

Interventions

Central Venous Catheters; Catheterization, Peripheral

Intervention Hierarchy (Ancestors)

Vascular Access Devices; Catheters; Equipment and Supplies; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Amy Bardin

  Teleflex Incorporated Clinical and Medical Affairs

  STUDY DIRECTOR

Central Study Contacts

Aderinola (Derin) Ogundimu, PhD, ACRP, PMP

CONTACT

469.569.9223; aderinola.ogundimu@teleflex.com

Thomas E. Philbeck, Jr., PhD

CONTACT

2107227438; thomas.philbeck@teleflex.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: September 19, 2024
• Study Start: December 8, 2024
• Primary Completion (Estimated): December 7, 2034
• Study Completion (Estimated): December 7, 2034
• Last Updated: August 7, 2025

Record last verified: 2024-09

Locations

US (3)