Chronic Kidney DiseaseNCT02796300
Study to Compare Palindrome vs. BioFlo DuraMax Dialysis Catheters
A study testing Bioflo Dialysis Catheter and Palindrome Dialysis Catheter in people with Chronic Kidney Disease, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Bioflo Dialysis Catheter and Palindrome Dialysis Catheter
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2017to 25 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Short term catheter usage plan (< 1 months)
- No right jugular venous access
- Catheter use for bone marrow transplant or plasmapheresis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Palindrome vs. BioFlo DuraMax Hemodialysis Catheters: A Prospective Randomized Trial
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.
- Conditions
- Chronic Kidney Disease
- Being tested
- Bioflo Dialysis Catheter, Palindrome Dialysis Catheter
- Keywords
- bioflo, Duramax catheter, dialysis
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioflo Dialysis CatheterDevice
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.
Palindrome Dialysis CatheterDevice
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 group | Role | What they receive |
|---|---|---|
| Bioflo Goup | Active comparator | This group will have dialysis using the Bioflo catheter. Receives: Device: Bioflo Dialysis Catheter |
| Palindrome Group | Active comparator | This group will have dialysis using the Palindrome catheter. Receives: Device: Palindrome Dialysis Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters.
A comparison of the number of tPA used as an indicator of thrombosed catheter per month between two groups
Measured: 1 month
Secondary outcomes (3)
Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters.
A comparison of the number of tPA used as an indicator of thrombosed catheter per month between two groups in three month follow-up
Measured: 3 months
Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters.
If necessary, we will monitor the catheter thrombosis rate of Bioflo catheters vs. Palindrome catheters.
Measured: 6 months
Cost Analysis
To perform a cost-analysis and economic burden of using Bioflo catheters compared to Palindrome catheters due to catheter thrombosis and exchange.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study start20 Jan 2017
- Primary completion27 Mar 2019
- Study completion25 Jun 2019
Why it stopped: The sponsor decided to terminate the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Angiodynamics, Inc.
- Responsible party
- Principal investigator, Edward Wolfgang Lee, MD, University of California, Los Angeles
- Investigators
- Edward Lee, MD, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02796300
- Sponsor's protocol ID
- UCLA Bioflo 2016
- Status last verified
- Jul 2020
- First submitted
- 24 May 2016
- Last updated
- 13 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Palindrome vs. BioFlo DuraMax Hemodialysis Catheters: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT02796300
- Acronym / sponsor ID
- UCLA Bioflo 2016
- Conditions
- Chronic Kidney Disease
- Keywords
- bioflo, Duramax catheter, dialysis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The sponsor decided to terminate the study.
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Angiodynamics, Inc.
- Study start
- 20 Jan 2017 (actual)
- Primary completion
- 27 Mar 2019 (actual)
- Study completion
- 25 Jun 2019 (actual)
- First posted
- 10 Jun 2016 (estimated)
- Results
- Posted 13 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bioflo Goup | Active comparator | Device: Bioflo Dialysis CatheterThis group will have dialysis using the Bioflo catheter. |
| Palindrome Group | Active comparator | Device: Palindrome Dialysis CatheterThis group will have dialysis using the Palindrome catheter. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Short term catheter usage plan (< 1 months)
- No right jugular venous access
- Catheter use for bone marrow transplant or plasmapheresis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioflo Dialysis CatheterThe 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 | Bioflo Goup |
| Palindrome Dialysis CatheterThe 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 Group |
Primary outcome
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
3 secondary outcomes
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
Cost Analysis
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Lee, MD, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioflo Dialysis Catheter and Palindrome Dialysis Catheter in people with Chronic Kidney Disease, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020.