Argyle Safety Fistula Cannula With Anti-reflux Valve Clinical Study
Argyle Fistula Cannula Pre-market, Prospective, Single Arm, Non-randomized, Interventional Study
1 other identifier
interventional
40
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2024
Shorter than P25 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2023
CompletedFirst Posted
Study publicly available on registry
July 3, 2023
CompletedStudy Start
First participant enrolled
March 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2024
CompletedMarch 17, 2026
March 1, 2026
9 months
January 19, 2023
March 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Successful Cannulations
through study completion, an average of 1 year
Cannulation Locations with securement details
through study completion, an average of 1 year
Access-related complications requiring procedural intervention
through study completion, an average of 1 year
Compare prescribed blood flow rates
through study completion, an average of 1 year
Dialysis adequacy
through study completion, an average of 1 year
- +3 more secondary outcomes
Other Outcomes (2)
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
Time to successful cannulation
During procedure
Study Arms (1)
Argyle Fistula Cannula Subjects
EXPERIMENTALAll subjects enrolled in the study and treated with the Argyle Safety Fistula Cannula with Anti-reflux Valve
Interventions
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
DaVita Hartford
Hartford, Connecticut, 06082, United States
DaVita Columbus
Columbus, Georgia, 31904, United States
DaVita Norfolk
Norfolk, Virginia, 23505, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2023
First Posted
July 3, 2023
Study Start
March 10, 2024
Primary Completion
December 15, 2024
Study Completion
December 15, 2024
Last Updated
March 17, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share