Argyle Safety Fistula Cannula With Anti-reflux Valve Clinical Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Argyle Fistula Cannula Subjects 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
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
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Outcome Measures
Primary Outcome Measures
- Successful Hemodialysis Sessions [through study completion, an average of 1 year]
The primary objective is the percentage of successful hemodialysis sessions using the Argyle™ Safety Fistula Cannula with Anti-reflux Valve.
Secondary Outcome Measures
- Successful Cannulations [through study completion, an average of 1 year]
Report the percentage of successful cannulations to achieve successful cannulation in each subject
- Cannulation Locations with securement details [through study completion, an average of 1 year]
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
- Access-related complications requiring procedural intervention [through study completion, an average of 1 year]
Quantify the number of subjects who had a procedure to correct access-related complications
- Compare prescribed blood flow rates [through study completion, an average of 1 year]
Compare prescribed blood flow rates with plastic fistula cannula to average blood flow achieved
- Dialysis adequacy [through study completion, an average of 1 year]
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.
- Cannulator Satisfaction Questionnaire [through study completion, an average of 1 year]
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.
- Subject Satisfaction Questionnaire [through study completion, an average of 1 year]
Characterize subject satisfaction using standardized survey to assess insertion pain
- Impact of delay between training and use of device [through study completion, an average of 1 year]
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.
Other Outcome Measures
- Summary of Needle Stick Injury within past 6 months from start of study by investigational site [in the past 6 months from the start of the study]
Summarize any reported needle stick injury reports in the past 6 months from the start of the study, as permitted by the investigational site
- Time to successful cannulation [During procedure]
Report the time required to achieve successful cannulation
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject who is aged 18 years or older who signed informed consent
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Subject is undergoing in-center hemodialysis
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Subject has an arteriovenous fistulae (AVF) fistula that was determined to be mature by standard clinical definition
Exclusion Criteria:
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Subject is enrolled in another study that could confound the results of this study, without documented pre-approval
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Subject with an existing arteriovenous graft
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Subjects with known allergies to plastics
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Subjects who are unable to read or respond to the questionnaire about satisfaction
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Medtronic - MITG
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MDT19046