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Hemodialysis Catheter

Pristine™ Long-Term Hemodialysis Catheter for Chronic Kidney Failure

N/A
Waitlist Available
Led By Jeffrey Hoggard, MD
Research Sponsored by C. R. Bard
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 at 3 months post index procedure.
Awards & highlights

Study Summary

This trial will study the safety and performance of a new long-term hemodialysis catheter.

Eligible Conditions
  • Hemodialysis Access Failure
  • Chronic Kidney Failure
  • Catheter-related Bloodstream Infection
  • Hemodialysis Complication
  • Kidney Failure
  • Hemodialysis Catheter Infection

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Complication Rate of the Pristine™ Catheter
Secondary outcome measures
Overall Catheter Survival Rate
Overall Participant Survival Rate
Overall Patency Rate
+3 more
Other outcome measures
Kit Component Safety and Performance

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pristine™ Long-Term Hemodialysis CatheterExperimental Treatment1 Intervention
The Pristine™ Long-Term Hemodialysis Catheter is a chronic hemodialysis catheter consisting of a dual lumen radiopaque shaft with a pre-formed split tip, which enables long-term vascular access for hemodialysis. The device is intended to be used in patients suffering from chronic kidney disease. The Pristine™ Catheter will be placed according to the Instructions for Use (IFU).

Find a Location

Who is running the clinical trial?

C. R. BardLead Sponsor
103 Previous Clinical Trials
39,458 Total Patients Enrolled
Jeffrey Hoggard, MDPrincipal InvestigatorRaleigh Access Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
The Pristine Post-Market Study
2022. "The Pristine Post-Market Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05228132.
~49 spots leftby Apr 2025
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