The Pristine Post-Market Study (NCT05228132) | Clinical Trial Compass
TerminatedNot Applicable
The Pristine Post-Market Study
Stopped: Terminated due to considerable changes in the clinical landscape post Covid-19, leading to difficulties executing the study. Results were blinded at time of termination.
United States142 participantsStarted 2022-05-16
Plain-language summary
This is a prospective, multi-center, single-arm study designed to assess the safety and performance of the Pristineâ„¢ Long-Term Hemodialysis Catheter.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Overall Complication Rate of the Pristineâ„¢ Catheter
✕. 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.