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Vascular Access
Endovascular vs Surgical Techniques for Dialysis Fistula Creation (ESAVFO Trial)
N/A
Waitlist Available
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Study will include participants who are 18 years and older who are scheduled to have an AVF
Preoperative ultrasound showed feasibility to have an endo-vascular AVF vs surgical upper arm AVF
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-2 years
Awards & highlights
ESAVFO Trial Summary
This trial will compare two techniques for creating an arteriovenous fistula for dialysis, the traditional surgical method and a new per-cutaneous technique, to see which is more effective.
Who is the study for?
This trial is for adults over 18 who need an arteriovenous fistula (AVF) for dialysis and can have either an endovascular AVF or a surgical upper arm AVF, as shown by preoperative ultrasound. It's not for those under 18 or patients eligible only for a low forearm AVF.Check my eligibility
What is being tested?
The study compares two methods of creating dialysis access: the traditional surgery (Surgical AVFs) and a newer, less invasive technique using catheters (Endo-AVFs). Participants will be randomly assigned to one of these techniques at the University of Alabama at Birmingham.See study design
What are the potential side effects?
Potential side effects may include complications like infection, clotting, bleeding from the site where the fistula was created, or issues with fistula maturation which could affect its usability for dialysis.
ESAVFO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 or older and scheduled for an arteriovenous fistula procedure.
Select...
My ultrasound before surgery showed I can have a special type of vein access for dialysis.
ESAVFO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0-2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Surgical Portacaval Shunt (procedure)
Secondary outcome measures
Clinical fistula maturity
Fistula survival
ESAVFO Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Endo-vascular AVFExperimental Treatment1 Intervention
Participants who initiated dialysis with a catheter or have advanced chronic kidney disease ,these patients who an endo-vascular AVF intervention group that will undergo a per-cutaneous AVF creation.
Group II: Surgical AVFsActive Control1 Intervention
Participants who initiated dialysis with a catheter or have advanced chronic kidney disease ,these patients who an Surgical AVF intervention group that will undergo a routine surgical AVF creation.
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,565 Previous Clinical Trials
2,268,337 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My ultrasound before surgery showed I can have a special type of vein access for dialysis.I am 18 or older and scheduled for an arteriovenous fistula procedure.I am under 18 years old.I am eligible for a specific type of arm vein access for dialysis.
Research Study Groups:
This trial has the following groups:- Group 1: Surgical AVFs
- Group 2: Endo-vascular AVF
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are expected to join this research trial?
"Indeed, clinicaltrials.gov indicates that this trial is actively recruiting participants. The research was first published on May 1st 2022 and has seen its most recent update on the 6th of the same month. 80 individuals will be recruited from a single site for this study."
Answered by AI
Is this investigation currently seeking participants?
"Data available on clinicaltrials.gov indicates that this trial is actively seeking participants, first being listed on May 1st of 2022 and last updated only a few days ago on the 6th."
Answered by AI
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