Argyle Safety Fistula Cannula With Anti-reflux Valve Clinical Study
NCT ID: NCT05927532
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2024-03-10
2024-12-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Argyle Fistula Cannula Subjects
All subjects enrolled in the study and treated with the Argyle Safety Fistula Cannula with Anti-reflux Valve
Argyle Safety Fistula Cannula with Anti-Reflux Valve
The Argyle Safety Fistula Cannula with Anti-reflux Valve will be used 3x a week for 12 weeks in subjects with an arteriovenous fistulae (AVF) fistula
Interventions
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Argyle Safety Fistula Cannula with Anti-Reflux Valve
The Argyle Safety Fistula Cannula with Anti-reflux Valve will be used 3x a week for 12 weeks in subjects with an arteriovenous fistulae (AVF) fistula
Eligibility Criteria
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Inclusion Criteria
* 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 with an existing arteriovenous graft
* Subjects with known allergies to plastics
* Subjects who are unable to read or respond to the questionnaire about satisfaction
18 Years
ALL
No
Sponsors
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Medtronic - MITG
INDUSTRY
Responsible Party
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Locations
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DaVita Hartford
Hartford, Connecticut, United States
DaVita Columbus
Columbus, Georgia, United States
DaVita Norfolk
Norfolk, Virginia, United States
Countries
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Other Identifiers
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MDT19046
Identifier Type: -
Identifier Source: org_study_id