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Trial record 1 of 2 for:    Bioflo Duramax dialysis catheter
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Study to Compare Palindrome vs. BioFlo DuraMax Dialysis Catheters

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: NCT02796300
Recruitment Status : Terminated (The sponsor decided to terminate the study.)
First Posted : June 10, 2016
Results First Posted : April 13, 2020
Last Update Posted : August 13, 2020
Sponsor:
Collaborator:
Angiodynamics, Inc.
Information provided by (Responsible Party):
Edward Wolfgang Lee, MD, University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE May 24, 2016
First Posted Date  ICMJE June 10, 2016
Results First Submitted Date  ICMJE March 26, 2020
Results First Posted Date  ICMJE April 13, 2020
Last Update Posted Date August 13, 2020
Actual Study Start Date  ICMJE January 20, 2017
Actual Primary Completion Date March 27, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2020)
Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters. [ Time Frame: 1 month ]
A comparison of the number of tPA used as an indicator of thrombosed catheter per month between two groups
Original Primary Outcome Measures  ICMJE
 (submitted: June 9, 2016)
Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters. [ Time Frame: 1 month ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2020)
  • Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters. [ Time Frame: 3 months ]
    A comparison of the number of tPA used as an indicator of thrombosed catheter per month between two groups in three month follow-up
  • Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters. [ Time Frame: 6 months ]
    If necessary, we will monitor the catheter thrombosis rate of Bioflo catheters vs. Palindrome catheters.
  • Cost Analysis [ Time Frame: 3 months ]
    To perform a cost-analysis and economic burden of using Bioflo catheters compared to Palindrome catheters due to catheter thrombosis and exchange.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2016)
  • Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters. [ Time Frame: 3 months ]
  • Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters. [ Time Frame: 6 months ]
    If necessary, we will monitor the catheter thrombosis rate of Bioflo catheters vs. Palindrome catheters.
  • Cost Analysis [ Time Frame: 3 months ]
    To perform a cost-analysis and economic burden of using Bioflo catheters compared to Palindrome catheters due to catheter thrombosis and exchange.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Compare Palindrome vs. BioFlo DuraMax Dialysis Catheters
Official Title  ICMJE Comparison of the Palindrome vs. BioFlo DuraMax Hemodialysis Catheters: A Prospective Randomized Trial
Brief Summary

Numerous catheter designs have been studied to increase efficacy and minimize complications of catheter hemodialysis. Major complications of catheters include thrombosis, central venous stenosis, infection, and dialysis inadequacy. Thrombosis must be avoided if possible because using too many catheters may exhaust all of the catheter insertion sites on the body, as well as increase the risk of infection. This prospective study compares the complications and general outcomes of patients who receive hemodialysis using the mainstream Palindrome catheter versus the newer BioFlo DuraMax catheter.

This study will examine outcomes of patients who receive hemodialysis using either the Palindrome catheter or the BioFlo catheter. Patients will be observed and outcomes will be recorded for three to six months. Outcomes will be analyzed and compared to draw conclusions on which catheter produces less catheter thrombosis.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Kidney Disease
Intervention  ICMJE
  • Device: Bioflo Dialysis Catheter
    The catheter placement procedure will be performed in the interventional radiology suite. The catheter will be inserted subcutaneously through incision in the chest through the tract.
  • Device: Palindrome Dialysis Catheter
    The catheter placement procedure will be performed in the interventional radiology suite. The catheter will be inserted subcutaneously through incision in the chest through the tract.
Study Arms  ICMJE
  • Active Comparator: Bioflo Goup
    This group will have dialysis using the Bioflo catheter.
    Intervention: Device: Bioflo Dialysis Catheter
  • Active Comparator: Palindrome Group
    This group will have dialysis using the Palindrome catheter.
    Intervention: Device: Palindrome Dialysis Catheter
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 3, 2019)
32
Original Estimated Enrollment  ICMJE
 (submitted: June 9, 2016)
60
Actual Study Completion Date  ICMJE June 25, 2019
Actual Primary Completion Date March 27, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Males and females 18 - 65 years of age;
  2. First de novo dialysis catheter placement or second catheter exchange, no more than 3 replacements on a same site
  3. Requiring at least 3 months dialysis catheter usage
  4. No clinical or radiographic evidence of superior vena cava (SVC) narrowing
  5. Patent right internal or external jugular vein
  6. Willing to provide the dialysis center information for F/U
  7. No known diagnosis of hypercoagulopathy

Exclusion Criteria:

  1. Short term catheter usage plan (< 1 months)
  2. No right jugular venous access
  3. Catheter use for bone marrow transplant or plasmapheresis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02796300
Other Study ID Numbers  ICMJE UCLA Bioflo 2016
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Edward Wolfgang Lee, MD, University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE Angiodynamics, Inc.
Investigators  ICMJE
Principal Investigator: Edward Lee, MD, PhD University of California, Los Angeles
PRS Account University of California, Los Angeles
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP