The Pristine Post-Market Study

Stopped early · Not applicable

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

In brief

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

Key facts

Study ID

NCT05228132

Run by

C. R. Bard

People needed

142

Starts

2022-05-16

Expected to finish

2022-09-21

Last updated by the study team

2024-04-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The participant or legally designated representative must voluntarily sign and date the approved Informed Consent Form (ICF) prior to collection of study-specific data or performance of study-specific procedures.
• The participant must be willing and able to comply with protocol requirements, including all study visits and procedures.
• The participant must be either a male or non-pregnant female ≥18 years of age.
• The participant must have a diagnosis of End Stage Renal Disease with indication for a tunneled dialysis catheter creation.
• Participant must require chronic hemodialysis treatments 3 times per week with intended use of the Pristine™ Long-Term Hemodialysis Catheter.
• The participant meets the indications for hemodialysis use and does not meet any of the contraindications per the Pristine Instructions for Use (IFU).
• The participant must have a patent jugular vein or subclavian vein.

You may not qualify if…

• The participant has known central venous stenosis
• Based on the local primary investigator's discretion, the patient would not be an appropriate study candidate.
• The participant has already undergone an AVF or AVG procedure and is awaiting maturation.
• The participant has an active infection at the time of study enrollment.
• The participant has a presence of bacteremia or infection within 7 days prior to enrollment.
• The participant has a history neutropenia or a history of severe immunodeficiency disease.
• The participant has uncontrolled abnormal coagulation parameters and are at additional risk for clotting or excessive bleeding at time of enrollment per physicians opinion.
• The participant has a known allergy, intolerance or sensitivity to heparin, or previous incidence of heparin-induced thrombocytopenia.
• The participant has a known allergy or hypersensitivity to any of the device materials or Ethylene oxide (EtO).
• The participant has another medical condition or treatment, which in the opinion of the investigator, the participant may be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow for completion of study procedures and follow-up.
• The participant is currently participating in an investigational drug or another device study that has not completed the study treatment or that clinically interferes with the study endpoints. Note: Studies requiring extended follow-up visits for products that were investigational but have since become commercially available, are not considered investigational studies.

Where it is running

• Trinity Research Group LLC — Dothan, Alabama, United States
• Yale University — New Haven, Connecticut, United States
• Louisiana State University Health Shreveport Medical Center — Shreveport, Louisiana, United States
• Henry Ford Health System — Detroit, Michigan, United States
• North Carolina Nephrology, PA — Raleigh, North Carolina, United States
• JML Research Associates — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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