Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Kidney Disease
Interventions Device: Bioflo Dialysis Catheter
Device: Palindrome Dialysis Catheter
Enrollment 32
Recruitment Details Recruitment period = 01/2017 to 12/2018 Location = UCLA Santa Monica Hospital
Pre-assignment Details No significant events occurred in this study prior to assignment to a group
Arm/Group Title Bioflo Goup Palindrome Group
Hide Arm/Group Description

This group will have dialysis using the Bioflo catheter.

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.

This group will have dialysis using the Palindrome catheter.

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.

Period Title: Overall Study
Started 10 22
Completed 10 22
Not Completed 0 0
Arm/Group Title Bioflo Goup Palindrome Group Total
Hide Arm/Group Description

This group will have dialysis using the Bioflo catheter.

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.

This group will have dialysis using the Palindrome catheter.

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.

Total of all reporting groups
Overall Number of Baseline Participants 10 22 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 22 participants 32 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
  80.0%
10
  45.5%
18
  56.3%
>=65 years
2
  20.0%
12
  54.5%
14
  43.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 22 participants 32 participants
50.2  (14.7) 61.2  (18.6) 57.8  (18.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 22 participants 32 participants
Female
3
  30.0%
7
  31.8%
10
  31.3%
Male
7
  70.0%
15
  68.2%
22
  68.8%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 22 participants 32 participants
10 22 32
1.Primary Outcome
Title Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters.
Hide Description A comparison of the number of tPA used as an indicator of thrombosed catheter per month between two groups
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bioflo Goup Palindrome Group
Hide Arm/Group Description:

This group will have dialysis using the Bioflo catheter.

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.

This group will have dialysis using the Palindrome catheter.

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.

Overall Number of Participants Analyzed 10 22
Mean (Standard Error)
Unit of Measure: catheter thrombosis per month
4.3  (0.56) 7.27  (0.49)
2.Secondary Outcome
Title Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters.
Hide Description A comparison of the number of tPA used as an indicator of thrombosed catheter per month between two groups in three month follow-up
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Two patients in the Palindrome group were not included in this outcome measure analysis. One patient received the kidney transplant during the 3 month follow-up and the second patient died during the 3 month follow-up
Arm/Group Title Bioflo Goup Palindrome Group
Hide Arm/Group Description:

This group will have dialysis using the Bioflo catheter.

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.

This group will have dialysis using the Palindrome catheter.

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.

Overall Number of Participants Analyzed 10 20
Mean (Standard Error)
Unit of Measure: catheter thrombosis per 3 months
8.6  (0.81) 12.4  (1.07)
3.Secondary Outcome
Title Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters.
Hide Description If necessary, we will monitor the catheter thrombosis rate of Bioflo catheters vs. Palindrome catheters.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
6 month data were not collected due to a stopping rule invoked after the 3-month data were analyzed
Arm/Group Title Bioflo Goup Palindrome Group
Hide Arm/Group Description:

This group will have dialysis using the Bioflo catheter.

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.

This group will have dialysis using the Palindrome catheter.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Cost Analysis
Hide Description To perform a cost-analysis and economic burden of using Bioflo catheters compared to Palindrome catheters due to catheter thrombosis and exchange.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Two patients in the Palindrome group were not included in this outcome measure analysis. One patient received the kidney transplant during the 3 month follow-up and the second patient died during the 3 month follow-up
Arm/Group Title Bioflo Goup Palindrome Group
Hide Arm/Group Description:

This group will have dialysis using the Bioflo catheter.

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.

This group will have dialysis using the Palindrome catheter.

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.

Overall Number of Participants Analyzed 10 20
Mean (Standard Error)
Unit of Measure: US Dollar
60200  (5638.75) 78909  (8716.53)
Time Frame 6 Months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bioflo Goup Palindrome Group
Hide Arm/Group Description

This group will have dialysis using the Bioflo catheter.

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.

This group will have dialysis using the Palindrome catheter.

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.

All-Cause Mortality
Bioflo Goup Palindrome Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   3/22 (13.64%) 
Hide Serious Adverse Events
Bioflo Goup Palindrome Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/22 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bioflo Goup Palindrome Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/22 (0.00%) 
An early termination occurred due to the decision made by the sponsor and PI. This led to smaller numbers of subjects analyzed than originally planned.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Principal Investigator
Organization: UCLA Medical Center
Phone: 310-267-8771
EMail: EdwardLee@mednet.ucla.edu
Layout table for additonal information
Responsible Party: Edward Wolfgang Lee, MD, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02796300    
Other Study ID Numbers: UCLA Bioflo 2016
First Submitted: May 24, 2016
First Posted: June 10, 2016
Results First Submitted: March 26, 2020
Results First Posted: April 13, 2020
Last Update Posted: August 13, 2020