Argyle Safety Fistula Cannula With Anti-reflux Valve Clinical Study

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

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.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Failure on Dialysis
• Intervention / Treatment: Device: Argyle Safety Fistula Cannula with Anti-Reflux Valve

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06082
      • DaVita Hartford
  • Georgia
    • Columbus, Georgia, United States, 31904
      • DaVita Columbus
  • Virginia
    • Norfolk, Virginia, United States, 23505
      • DaVita Norfolk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Summary of Needle Stick Injury within past 6 months from start of study by investigational site	Summarize any reported needle stick injury reports in the past 6 months from the start of the study, as permitted by the investigational site	in the past 6 months from the start of the study
Time to successful cannulation	Report the time required to achieve successful cannulation	During procedure

Collaborators and Investigators

• Sponsor: Mozarc Medical US LLC

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2024
• Primary Completion (Actual): December 15, 2024
• Study Completion (Actual): December 15, 2024

Study Registration Dates

• First Submitted: January 19, 2023
• First Submitted That Met QC Criteria: June 22, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Fistula
• Other Study ID Numbers: MDT19046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes