Clinical trial NCT06604039: A Clinical Registry to Demonstrate the Safety and Performance of Teleflex Vascular Access Devices
Official title: A Prospective Clinical Registry Evaluating Safety and Performance of Teleflex Vascular Access Devices
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Vascular Access Device
Lead sponsor: Teleflex
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 2500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Catheter devices: successful use of the device without removal due to device-related adverse events
timeFrame: Within 7 days after subject device removal
measure: Arrow VPS Rhythm DXL catheter tip positioning system: Successful verification of catheter tip location
timeFrame: Immediately after subject device removal
Secondary outcomes:
measure: Device-related adverse events
timeFrame: Within 7 days after subject device removal
measure: Device-related adverse events within 7 days of device removal
timeFrame: Within 7 days after subject device removal
Other outcomes:
measure: Adverse event caused by use of device accessory
timeFrame: Within 7 days after subject device removal
measure: Device accessory used successfully
timeFrame: Within 7 days after subject device removal
measure: Duration of use
timeFrame: Within 7 days after subject device removal
measure: Usability score
timeFrame: Within 7 days after subject device removal
Locations:
Study officials:
affiliation: Teleflex Incorporated Clinical and Medical Affairs
name: Thomas E Philbeck, PhD
role: STUDY_DIRECTOR
References: