Status:
TERMINATED
The Pristine Post-Market Study
Lead Sponsor:
C. R. Bard
Conditions:
Kidney Failure, Chronic
Hemodialysis Complication
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 (U...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 21 2022
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT05228132
Start Date
May 16 2022
End Date
September 21 2022
Last Update
April 11 2024
Active Locations (6)
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1
Trinity Research Group LLC
Dothan, Alabama, United States, 36301
2
Yale University
New Haven, Connecticut, United States, 06520
3
Louisiana State University Health Shreveport Medical Center
Shreveport, Louisiana, United States, 71103
4
Henry Ford Health System
Detroit, Michigan, United States, 48202