Argyle Safety Fistula Cannula With Anti-reflux Valve Clinical Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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End Stage Renal Failure on Dialysis

Intervention / Treatment
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* Device: Argyle Safety Fistula Cannula with Anti-Reflux Valve


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Argyle Fistula Cannula Subjects<br>All subjects enrolled in the study and treated with the Argyle Safety Fistula Cannula with Anti-reflux Valve | Device: Argyle Safety Fistula Cannula with Anti-Reflux Valve<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful Hemodialysis Sessions | The primary objective is the percentage of successful hemodialysis sessions using the Argyle™ Safety Fistula Cannula with Anti-reflux Valve. | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful Cannulations | Report the percentage of successful cannulations to achieve successful cannulation in each subject | through study completion, an average of 1 year | 
| Cannulation Locations with securement details | Characterize cannulation locations and details on the securement of the cannulas after taping during the hemodialysis session by evaluating the staff-reported insertion sites captured on the Dialysis Session case report form | through study completion, an average of 1 year | 
| Access-related complications requiring procedural intervention | Quantify the number of subjects who had a procedure to correct access-related complications | through study completion, an average of 1 year | 
| Compare prescribed blood flow rates | Compare prescribed blood flow rates with plastic fistula cannula to average blood flow achieved | through study completion, an average of 1 year | 
| Dialysis adequacy | Compare baseline dialysis adequacy (e.g., spKt/V and urea reduction ratio (URR) to measure collected at 1, 3, 6 and 12 weeks). The average spKt/V and URR will be compared to measurements reported at basline using steel needles. A repeated measures approach will be utilized to compare baseline to follow-up dialysis adequacy measurements. | through study completion, an average of 1 year | 
| Cannulator Satisfaction Questionnaire | Assess inserter satisfaction (survey), i.e., ability to access deep fistulas, insertion locations, securement technique, ability to determine proper placement without the usual pulsing flashback seen with traditional needles. Mean satisfaction score (and associated 95% confidence intervals) prior to first use and following final cannulation will be reported. | through study completion, an average of 1 year | 
| Subject Satisfaction Questionnaire | Characterize subject satisfaction using standardized survey to assess insertion pain | through study completion, an average of 1 year | 
| Impact of delay between training and use of device | Evaluate any impact of delay between training and use of the subject devices, or time elapsed between cases for each clinician and successful and unsuccessful cannulations. The proportion of successful and unsuccessful cannulations will be predicted with clinician and time between training and cannulation attempt using logistic regression. Statistical significance of the covariate time between training and cannulation attempt will be reported. | through study completion, an average of 1 year |