Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06604039
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
A Clinical Registry to Demonstrate the Safety and Performance of Teleflex Vascular Access Devices
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Clinical Registry Evaluating Safety and Performance of Teleflex Vascular Access Devices
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VADER
Brief Summary:
The general objective of Teleflexs Vascular Access Device Registry VADER is to provide high-quality Level 3 or better data on the performance safety and clinical benefits of Teleflexs 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 Teleflexs 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 navigationtip 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
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 navigationtip 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None