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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

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.


Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Device: Bioflo Dialysis Catheter Device: Palindrome Dialysis Catheter Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of the Palindrome vs. BioFlo DuraMax Hemodialysis Catheters: A Prospective Randomized Trial
Actual Study Start Date : January 20, 2017
Actual Primary Completion Date : March 27, 2019
Actual Study Completion Date : June 25, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Bioflo Goup
This group will have dialysis using the Bioflo catheter.
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.

Active Comparator: Palindrome Group
This group will have dialysis using the Palindrome catheter.
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796300


Locations
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United States, California
UCLA Medical Center
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Angiodynamics, Inc.
Investigators
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Principal Investigator: Edward Lee, MD, PhD University of California, Los Angeles
  Study Documents (Full-Text)

Documents provided by Edward Wolfgang Lee, MD, University of California, Los Angeles:
Informed Consent Form  [PDF] February 21, 2018

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Responsible Party: Edward Wolfgang Lee, MD, MD, PhD, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02796300    
Other Study ID Numbers: UCLA Bioflo 2016
First Posted: June 10, 2016    Key Record Dates
Results First Posted: April 13, 2020
Last Update Posted: August 13, 2020
Last Verified: July 2020

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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
Keywords provided by Edward Wolfgang Lee, MD, University of California, Los Angeles:
bioflo
Duramax catheter
dialysis
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency