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Hemodialysis Catheter
Pristine™ Long-Term Hemodialysis Catheter for 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
No Placebo-Only Group
Summary
This trial is testing the safety and performance of the Pristine™ Long-Term Hemodialysis Catheter in patients with severe kidney disease who need dialysis. The catheter is a special tube that helps these patients receive their treatments more easily. It is placed in a large vein to provide a reliable access point for dialysis.
Eligible Conditions
- Hemodialysis Catheter Infection
- Kidney Failure
- Chronic Kidney Failure
- Catheter-related Bloodstream Infection
- Hemodialysis Complication
- Chronic Kidney Disease
- Hemodialysis Access Failure
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 3 months post index procedure.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3 months post index procedure.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Complication Rate of the Pristine™ Catheter
Secondary study objectives
Overall Catheter Survival Rate
Overall Participant Survival Rate
Overall Patency Rate
+3 moreOther study objectives
Kit Component Safety and Performance
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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).
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Who is running the clinical trial?
C. R. BardLead Sponsor
105 Previous Clinical Trials
39,649 Total Patients Enrolled
1 Trials studying Kidney Failure
14 Patients Enrolled for Kidney Failure
Jeffrey Hoggard, MDPrincipal InvestigatorRaleigh Access Center
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