Study to Compare Palindrome vs. BioFlo DuraMax Dialysis Catheters
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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
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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 |
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Chronic Kidney Disease | Device: Bioflo Dialysis Catheter Device: Palindrome Dialysis Catheter | Not Applicable |
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 |

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

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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 |
Inclusion Criteria:
- Males and females 18 - 65 years of age;
- First de novo dialysis catheter placement or second catheter exchange, no more than 3 replacements on a same site
- Requiring at least 3 months dialysis catheter usage
- No clinical or radiographic evidence of superior vena cava (SVC) narrowing
- Patent right internal or external jugular vein
- Willing to provide the dialysis center information for F/U
- No known diagnosis of hypercoagulopathy
Exclusion Criteria:
- Short term catheter usage plan (< 1 months)
- No right jugular venous access
- Catheter use for bone marrow transplant or plasmapheresis

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
United States, California | |
UCLA Medical Center | |
Los Angeles, California, United States, 90095 |
Principal Investigator: | Edward Lee, MD, PhD | University of California, Los Angeles |
Documents provided by Edward Wolfgang Lee, MD, University of California, Los Angeles:
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 |
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 |
bioflo Duramax catheter dialysis |
Kidney Diseases Renal Insufficiency, Chronic Urologic Diseases Renal Insufficiency |