Study to Compare Palindrome vs. BioFlo DuraMax Dialysis Catheters

NCT ID: NCT02796300

Last Updated: 2020-08-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-20
• Study Completion Date: 2019-06-25

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.

Conditions

Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bioflo Goup

This group will have dialysis using the Bioflo catheter.

Group Type: ACTIVE_COMPARATOR

Bioflo Dialysis Catheter

Intervention Type: DEVICE

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 Group

This group will have dialysis using the Palindrome catheter.

Group Type: ACTIVE_COMPARATOR

Palindrome Dialysis Catheter

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Angiodynamics, Inc.

INDUSTRY

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Edward Wolfgang Lee, MD

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edward Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

UCLA Medical Center

Los Angeles, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

UCLA Bioflo 2016

Identifier Type: -

Identifier Source: org_study_id