End Stage Renal Failure on Dialysis
Conditions
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.
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.
Interventions
DEVICEArgyle 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
Sponsors
Mozarc Medical US LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed