Finding studies
Finding studies
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Lead
Angiodynamics, Inc.
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: * Incidence of other catheter-related complications, inclusive of catheter occlusion, catheter-related infection, technical failures, and premature catheter removals * Incidence of catheter occlusion (independently from other catheter-related complications) Additionally, economic outcomes with respect to medical resource utilization requirements will be compared between the two catheter groups (at US sites only).
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
