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Study to Compare Palindrome vs. BioFlo DuraMax Dialysis Catheters

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ClinicalTrials.gov Identifier: NCT02796300
Recruitment Status : Recruiting
First Posted : June 10, 2016
Last Update Posted : May 8, 2018
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 Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 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 ]

Secondary Outcome Measures :
  1. Catheter thrombosis rate of Bioflo catheters vs. Palindrome catheters. [ Time Frame: 3 months ]
  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


Contacts
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Contact: Victoria Rueda, MPH 310-794-8334 VRueda@mednet.ucla.edu
Contact: Saima Chaabane, PhD 310-794-8995 schaabane@mednet.ucla.edu

Locations
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United States, California
UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Victoria Rueda, MPH    310-794-8334    vrueda@mednet.ucla.edu   
Contact: Saima Chaabane, PhD    310-794-8995    schaabane@mednet.ucla.edu   
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

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Responsible Party: Edward Wolfgang Lee, MD, MD, PhD, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02796300     History of Changes
Other Study ID Numbers: UCLA Bioflo 2016
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: 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