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The main purpose of this study is to confirm whether the AngioDynamics BioFlo™ Peripherally Inserted Central Catheter (PICC) is associated with less formation of blood clots compared to another commercially available PICC.
Full description
Purpose:
To investigate whether the BioFlo™ PICC will be associated with a reduced incidence of catheter-related venous thrombosis (including both symptomatic and asymptomatic) compared to another commercially available PICC: the Bard® PowerPICC SOLO2®
Design:
This is a randomized, multi-center clinical study. The study is designed as a two-arm prospectively controlled trial. Participants will be randomly assigned to either the study or control catheter using a 1:1 schema.
Enrollment:
Four hundred sixteen (416) patients will be enrolled at four (4) to eight (8) study sites in order to obtain 354 evaluable patients.
Study Objectives:
The primary objective of this study is to investigate the incidence of catheter-related venous thrombosis in patients receiving either the 5 Fr BioFlo™ PICC catheter or the control catheter, i.e., the 5 Fr Dual-Lumen PowerPICC SOLO2® catheter.
Secondary objectives of this study are to investigate:
Additionally, economic outcomes with respect to medical resource utilization requirements will be compared between the two catheter groups (at US sites only).
Enrollment
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Inclusion criteria
Exclusion criteria
Anticipates or has presence of dialysis grafts or other ipsilateral intraluminal devices, including pacemakers (with the exception of peripheral IV catheters)
Has current or anticipated hematologic derangements, including:
Has central veno-occlusive disease
Has history of previous catheter-related thrombosis
Has arm identified for catheterization that exhibits any of the following (and the contralateral arm is also unsuitable for PICC placement based on the same criteria):
Is pregnant or lactating
Has been previously enrolled in this clinical study, or is participating in another clinical study that is contraindicative to the treatment or outcomes of this investigation
Primary purpose
Allocation
Interventional model
Masking
57 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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