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
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.

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

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 more

Other 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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