NCT05228132

The Pristine Post-Market Study

A Prospective, Multi-Center, Single-Arm Clinical Study of the Pristine™ Long-Term Hemodialysis Catheter

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multi-center, single-arm study designed to assess the safety and performance of the Pristine™ Long-Term Hemodialysis Catheter.

Detailed description

A total of 142 patients will be enrolled and have the Pristine™ Long-Term Hemodialysis Catheter placed. Under the current enrollment assumptions, up to 15 investigational sites in the United States (US) will participate. Eligible participants will have End Stage Renal Disease requiring hemodialysis through a tunneled dialysis catheter. Follow-up for all enrolled participants will be performed at 1-month, 3-months, 6-months, and 12-months post-Index Procedure.

Conditions

• Kidney Failure, Chronic
• Hemodialysis Complication
• Hemodialysis Catheter Infection
• Hemodialysis Access Failure
• Central Venous Catheter Related Bloodstream Infection
• End Stage Renal Disease

Interventions

Type	Name	Description
DEVICE	Pristine™ Long-Term Hemodialysis Catheter	Placement of the Pristine™ Long-Term Hemodialysis Catheter Placement.

Timeline

• Start date: 2022-05-16
• Primary completion: 2022-09-21
• Completion: 2022-09-21
• First posted: 2022-02-08
• Last updated: 2024-04-11
• Results posted: 2024-04-11

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study