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The Pristine Post-Market Study

NCT05228132 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2024-04-11

Study results available
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Summary

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

Conditions

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

Interventions

DEVICE

Pristine™ Long-Term Hemodialysis Catheter

Placement of the Pristine™ Long-Term Hemodialysis Catheter Placement.

Sponsors & Collaborators

  • C. R. Bard

    lead INDUSTRY

Principal Investigators

  • Jeffrey Hoggard, MD · Raleigh Access Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-16
Primary Completion
2022-09-21
Completion
2022-09-21
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05228132 on ClinicalTrials.gov