The Pristine Post-Market Study

Status Terminated

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05228132
Study type	Interventional
Source	C. R. Bard
Contact
Status	Terminated
Phase	N/A
Start date	May 16, 2022
Completion date	September 21, 2022

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