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Device

Argyle Fistula Cannula Subjects for Kidney Disease

N/A
Recruiting
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

Study 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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Successful Hemodialysis Sessions
Secondary outcome measures
Access-related complications requiring procedural intervention
Cannulation Locations with securement details
Cannulator Satisfaction Questionnaire
+5 more
Other outcome measures
Summary of Needle Stick Injury within past 6 months from start of study by investigational site
Time to successful cannulation

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
252 Previous Clinical Trials
300,646 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants enrolled in this clinical study?

"Indeed, data from clinicaltrials.gov indicates that this investigation is presently seeking participants. The study was initially listed on March 10th, 2024 and most recently revised on March 11th, 2024. There are openings for enrollment of up to 40 individuals across three designated sites."

Answered by AI

Are there currently opportunities for individuals to enroll in this research study?

"Affirmative, information on clinicaltrials.gov indicates that this investigation is actively seeking volunteers. The trial was initially published on March 10th, 2024, and last revised on March 11th of the same year. Approximately 40 participants are sought from three distinct locations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Argyle Safety Fistula Cannula With Anti-reflux Valve Clinical Study
2024. "Argyle Safety Fistula Cannula With Anti-reflux Valve Clinical Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05927532.
~27 spots leftby Oct 2024
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