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Bioflo Goup for Chronic Kidney Disease

N/A
Waitlist Available
Led By Edward Lee, MD, PhD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study 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.

Eligible Conditions
  • Chronic Kidney Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters.
Cost Analysis

Trial Design

2Treatment groups
Active Control
Group I: Bioflo GoupActive Control1 Intervention
This group will have dialysis using the Bioflo catheter.
Group II: Palindrome GroupActive Control1 Intervention
This group will have dialysis using the Palindrome catheter.

Find a Location

Who is running the clinical trial?

Angiodynamics, Inc.Industry Sponsor
23 Previous Clinical Trials
2,333 Total Patients Enrolled
University of California, Los AngelesLead Sponsor
1,541 Previous Clinical Trials
10,267,031 Total Patients Enrolled
Edward Lee, MD, PhDPrincipal InvestigatorUniversity of California, Los Angeles
~4 spots leftby Jun 2025