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Device
Fistula Cannula for Chronic Kidney Failure
N/A
Waitlist Available
Research Sponsored by Medtronic - MITG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to verify if the Argyle™ Safety Fistula Cannula with Anti-reflux Valve is safe and effective for use during hemodialysis treatment.
Who is the study for?
This trial is for adults over 18 who are undergoing in-center hemodialysis and have a mature arteriovenous fistulae (AVF) as per clinical standards. Participants must consent to the study's procedures.
What is being tested?
The Argyle Safety Fistula Cannula with Anti-reflux Valve, designed for safer and more effective hemodialysis treatment, is being tested for its safety and performance.
What are the potential side effects?
While specific side effects aren't listed, they may include discomfort at the cannulation site, potential infection risks, or issues related to dialysis access.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Successful Hemodialysis Sessions
Secondary study objectives
Access-related complications requiring procedural intervention
Cannulation Locations with securement details
Cannulator Satisfaction Questionnaire
+5 moreOther study objectives
Summary of Needle Stick Injury within past 6 months from start of study by investigational site
Time to successful cannulation
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Argyle Fistula Cannula SubjectsExperimental Treatment1 Intervention
All subjects enrolled in the study and treated with the Argyle Safety Fistula Cannula with Anti-reflux Valve
Find a Location
Who is running the clinical trial?
Medtronic - MITGLead Sponsor
263 Previous Clinical Trials
300,848 Total Patients Enrolled
1 Trials studying Kidney Failure
15 Patients Enrolled for Kidney Failure