NCT01921114

The PROOF Study: The PICC Related Obstruction Of Flow Study

A Randomized Prospective Multicenter Evaluation to Investigate the Incidence of Catheter Related Venous Thrombosis in Patients Undergoing Intravenous Therapy With the BioFlo™ Peripherally Inserted Central Catheter (PICC) or Bard® Dual-Lumen PowerPICC SOLO2®

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Angiodynamics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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: * 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).

Conditions

• Patients Indicated for a PICC for Any Medical Condition

Interventions

Type	Name	Description
DEVICE	BioFlo™ Peripherally Inserted Central Catheter (PICC)
DEVICE	Bard® Dual-Lumen PowerPICC SOLO2®

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-07-01
• Completion: 2014-08-01
• First posted: 2013-08-13
• Last updated: 2019-05-17
• Results posted: 2019-05-17

Locations

5 sites across 3 countries: United States, Canada, Switzerland