Argyle Safety Fistula Cannula With Anti-reflux Valve Clinical Study
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Details and patient eligibility
About
The purpose of the investigation is to confirm the safety and performance of the Argyle™ Safety Fistula Cannula with Anti-reflux Valve for hemodialysis treatment.
Full description
The study will be performed at up to 5 US hemodialysis clinics.
Qualified patients who choose to participate and sign informed consent will be enrolled in the study. The investigational sites chosen to participate in this study will be trained on the insertion procedure using plastic fistula cannulas according to established curriculum. A combination of didactic training followed by insertion using a cannulation arm will be conducted. Cannulation on consented subjects will begin after the inserter demonstrates proficiency on the cannulation arm. Proficiency definitions are outlined in the protocol. After two supervised (by Medtronic and/or dedicated, trained super user) successful cannulations on consented subjects, the clinician will be permitted to cannulate without supervision.
Data supporting the primary, secondary, and exploratory objectives will be captured following thirty-six (36) hemodialysis sessions for each enrolled subject.
Cannulations will be performed by a minimum of five different clinicians at up to 5 dialysis clinic sites.
The investigational sites chosen to participate in this study will be trained on the insertion procedure using plastic fistula cannulas for a pre-determined period and according to established curriculum. A combination of didactic training followed by insertion using a cannulation arm will be conducted. After two supervised (by Medtronic and/or dedicated, trained super user) successful cannulations on consented subjects, the clinician will be permitted to cannulate without supervision and the data collection for the primary and secondary objectives will begin. Hemodialysis sessions will be performed, according to the investigator's prescription, throughout the duration of the study. Dialysis adequacy will be verified at baseline and during the mid-week session on weeks 1, 3, 6 and 12. Other than the blood sampling, there are no study-specific procedures, other than cannulation with the Argyle™ Safety Fistula Cannula with Anti-Reflux Valve, that will be required.
Enrollment
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Volunteers
Inclusion criteria
- Subject who is aged 18 years or older who signed informed consent
- Subject is undergoing in-center hemodialysis
- Subject has an arteriovenous fistulae (AVF) fistula that was determined to be mature by standard clinical definition
Exclusion criteria
- Subject is enrolled in another study that could confound the results of this study, without documented pre-approval
- Subject with an existing arteriovenous graft
- Subjects with known allergies to plastics
- Subjects who are unable to read or respond to the questionnaire about satisfaction
Trial design
Primary purpose
Allocation
Interventional model
Masking
40 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Sr. Director of clinical research
Data sourced from clinicaltrials.gov
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