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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subject | Needing a vascular access device for therapy or diagnosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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Subjects who are scheduled to receive a vascular access procedure using at least one Teleflex vascular access device will be considered for enrollment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Amy Bardin | Teleflex Incorporated Clinical and Medical Affairs | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsville Hospital | Recruiting | Huntsville | Alabama | 35801 | United States |
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| ID | Term |
|---|---|
| D062905 | Central Venous Catheters |
| D002406 | Catheterization, Peripheral |
| ID | Term |
|---|---|
| D062666 | Vascular Access Devices |
| D057785 | Catheters |
| D004864 | Equipment and Supplies |
| D002404 | Catheterization |
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|
Incidence of device-related adverse events following removal
| Within 7 days after subject device removal |
| 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 |
| Loma Linda University Health | Recruiting | Loma Linda | California | 92354 | United States |
|
| Tufts Medical Center | Recruiting | Boston | Massachusetts | 02111 | United States |
|
| D013812 |
| Therapeutics |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |