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The PROOF Study: The PICC Related Obstruction Of Flow Study (PROOF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01921114
Recruitment Status : Terminated (Low enrollment)
First Posted : August 13, 2013
Results First Posted : May 17, 2019
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Angiodynamics, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Patients Indicated for a PICC for Any Medical Condition
Interventions Device: BioFlo™ Peripherally Inserted Central Catheter (PICC)
Device: Bard® Dual-Lumen PowerPICC SOLO2®
Enrollment 57
Recruitment Details  
Pre-assignment Details The study was prematurely terminated and the PI was blinded to study data, and therefore never had access to the data and does not have any information that might help us locate it. Additionally, AngioDynamics' IT team ran a thorough search for any data related to this study and no results were found.
Arm/Group Title BioFlo™ PICC Bard® PowerPICC SOLO2®
Hide Arm/Group Description

BioFlo™ Peripherally Inserted Central Catheter (PICC)

BioFlo™ Peripherally Inserted Central Catheter (PICC)

Bard® Dual-Lumen PowerPICC SOLO2®

Bard® Dual-Lumen PowerPICC SOLO2®

Period Title: Overall Study
Started 0 0
Completed 0 0
Not Completed 0 0
Arm/Group Title BioFlo™ PICC Bard® PowerPICC SOLO2® Total
Hide Arm/Group Description BioFlo™ Peripherally Inserted Central Catheter (PICC) Bard® Dual-Lumen PowerPICC SOLO2® Total of all reporting groups
Overall Number of Baseline Participants 0 0 0
Hide Baseline Analysis Population Description
The study was prematurely terminated and the PI was blinded to study data, and therefore never had access to the data and does not have any information that might help us locate it. Additionally, AngioDynamics' IT team ran a thorough search for any data related to this study and no results were found.
Age, Categorical  
Number Analyzed 0 participants 0 participants 0 participants
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male  
Number Analyzed 0 participants 0 participants 0 participants
Female
Male
Race (NIH/OMB)  
Number Analyzed 0 participants 0 participants 0 participants
American Indian or Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
More than one race
Unknown or Not Reported
Region of Enrollment  
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
Canada
United States
Switzerland
1.Primary Outcome
Title Incidence of Catheter-related Venous Thrombosis as Confirmed by Diagnostic Ultrasound
Hide Description [Not Specified]
Time Frame 10 (+/-3) days and any time there is clinically suspected venous thrombosis (as per standard of care)
Hide Outcome Measure Data
Hide Analysis Population Description
The study was prematurely terminated and the PI was blinded to study data, and therefore never had access to the data and does not have any information that might help us locate it. Additionally, AngioDynamics' IT team ran a thorough search for any data related to this study and no results were found.
Arm/Group Title BioFlo™ PICC Bard® PowerPICC SOLO2®
Hide Arm/Group Description:
BioFlo™ Peripherally Inserted Central Catheter (PICC)
Bard® Dual-Lumen PowerPICC SOLO2®
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Incidence of Other Catheter-related Complications
Hide Description

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)
Time Frame Up to 30 days post-insertion
Hide Outcome Measure Data
Hide Analysis Population Description
The study was prematurely terminated and the PI was blinded to study data, and therefore never had access to the data and does not have any information that might help us locate it. Additionally, AngioDynamics' IT team ran a thorough search for any data related to this study and no results were found.
Arm/Group Title BioFlo™ PICC Bard® PowerPICC SOLO2®
Hide Arm/Group Description:
BioFlo™ Peripherally Inserted Central Catheter (PICC)
Bard® Dual-Lumen PowerPICC SOLO2®
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Other Pre-specified Outcome
Title Medical Resource Utilization Data Analysis
Hide Description Economic outcomes with respect to medical resource utilization requirements will be compared between the two PICC groups. Only data from US sites will be used for this analysis.
Time Frame Up to 30 days post-insertion
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description The study was prematurely terminated and the PI was blinded to study data, and therefore never had access to the data and does not have any information that might help us locate it. Additionally, AngioDynamics' IT team ran a thorough search for any data related to this study and no results were found.
 
Arm/Group Title BioFlo™ PICC Bard® PowerPICC SOLO2®
Hide Arm/Group Description BioFlo™ Peripherally Inserted Central Catheter (PICC) Bard® Dual-Lumen PowerPICC SOLO2®
All-Cause Mortality
BioFlo™ PICC Bard® PowerPICC SOLO2®
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
BioFlo™ PICC Bard® PowerPICC SOLO2®
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
BioFlo™ PICC Bard® PowerPICC SOLO2®
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
The study was prematurely terminated and any data related to this study has been lost.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Alicia Conway
Organization: AngioDynamics
Phone: 774-249-8707
EMail: aconway@angiodynamics.com
Layout table for additonal information
Responsible Party: Angiodynamics, Inc.
ClinicalTrials.gov Identifier: NCT01921114     History of Changes
Other Study ID Numbers: VA-BF400
First Submitted: August 8, 2013
First Posted: August 13, 2013
Results First Submitted: May 16, 2019
Results First Posted: May 17, 2019
Last Update Posted: May 17, 2019