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

Not yet recruiting

• Conditions: Vascular Access Device
• Interventions: Device: Central venous catheter

• Registration Number: NCT06604039
• Lead 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

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 Timeline

• Study First Submitted: 2024-08-08
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-16
• Last Update Submitted: 2024-09-16
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Study Start: 2024-12-08
• Primary Completion: 2034-12-07
• Study Completion: 2034-12-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2500

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subject	Central venous catheter	Needing a vascular access device for therapy or diagnosis

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Device-related adverse events	Within 7 days after subject device removal	Incidence of device-related adverse events during placement or use
Device-related adverse events within 7 days of device removal	Within 7 days after subject device removal	Incidence of device-related adverse events following removal