A Clinical Registry to Demonstrate the Safety and Performance of Teleflex Vascular Access Devices
ConditionVascular Access Device
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorTeleflex
About this trial
The objective of Teleflex's Vascular Access Device Registry (VADER) is to provide high-quality data on the performance, safety, and clinical benefits of Teleflex's vascular access devices when used in a real-world setting
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Subjects who are scheduled to receive a vascular access procedure using at least one Teleflex vascular access device will be considered for enrollment.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Central venous catheter
DevicePlacement 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
Treatment groups
2,500 Participants
are divided into 1 treatment groupGroup A: Subject1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Within 7 days after subject device removal2
Arrow VPS Rhythm DXL catheter tip positioning system: Successful verification of catheter tip location
Successful verification of catheter tip location
Time frame
Immediately after subject device removalSecondary outcomes
1
Device-related adverse events
Incidence of device-related adverse events during placement or use
Time frame
Within 7 days after subject device removal2
Device-related adverse events within 7 days of device removal
Incidence of device-related adverse events following removal
Time frame
Within 7 days after subject device removalOther outcomes
1
Adverse event caused by use of device accessory
Clinicians used accessory safely
Time frame
Within 7 days after subject device removal2
Device accessory used successfully
Clinician used accessory successfully
Time frame
Within 7 days after subject device removal3
Duration of use
How long the device was in use for the patient
Time frame
Within 7 days after subject device removal4
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
Time frame
Within 7 days after subject device removal Source ClinicalTrials.gov