Argyle Fistula Cannula Pre-market, Prospective, Single Arm, Non-randomized, Interventional Study

Description

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.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

Trial Eligibility

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

Study Info

Interventions

Locations Recruiting

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