Your session is about to expire
← Back to Search
endoAVF vs surgAVF for Chronic Kidney Failure
N/A
Waitlist Available
Led By Karen Woo, MD, PhD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ESKD patients aged >18 who have chosen hemodialysis as their renal replacement option.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial aims to compare the outcomes of two different vascular access procedures - the traditional surgical approach and the newer endovascular approach - to determine which is more effective for patients with end-stage kidney disease.
Who is the study for?
This trial is for adults over 18 with end-stage kidney disease who need hemodialysis and have veins in their arms suitable for creating a vascular access. They must be able to consent to the study, not pregnant, nor planning pregnancy within six months, and not opting for peritoneal dialysis or a kidney transplant soon.Check my eligibility
What is being tested?
The study compares two methods of arteriovenous fistula (AVF) creation: traditional surgery (surgAVF) and a newer endovascular technique (endoAVF). Participants eligible for both will be randomly assigned to one method. The outcomes will help design a larger future study.See study design
What are the potential side effects?
While specific side effects are not listed here, surgical AVFs typically involve risks like infection, bleeding, or clotting at the site. EndoAVFs may have similar risks but could potentially reduce recovery time due to being less invasive.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 and have chosen hemodialysis for my kidney failure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Physiologically mature fistula
Secondary outcome measures
Number of interventions to achieve clinical maturation
Number of interventions to achieve physiologic maturation
clinically mature
+3 moreTrial Design
2Treatment groups
Active Control
Group I: surgAVFActive Control1 Intervention
Participant will undergo fistula creation through surgical means, which requires undergoing general anesthesia and opening the skin to create the fistula.
Group II: endoAVFActive Control1 Intervention
Participant will undergo fistula creation through endovascular surgical means, which does not require general anesthesia and is created by using a device that goes through the skin to create the fistula. The two devices that are currently FDA approved and used to create the endoAVF are the WavelinQ™ EndoAVF System and the Ellipsys® Vascular Access System.
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,528 Previous Clinical Trials
10,276,761 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,357 Previous Clinical Trials
4,315,096 Total Patients Enrolled
Karen Woo, MD, PhDPrincipal InvestigatorUniversity of California, Los Angeles
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The vein and artery where the device will be used need to be a certain size and be a specific distance apart from each other.The vein and artery where they connect are at least 2.0 mm in diameter.I understand the consent process and can give my consent.My upper arm veins are too small for certain vein surgeries.I prefer peritoneal dialysis and/or am planning a kidney transplant within 6 months.Your vein is very close to your radial artery, as seen on an ultrasound.My surgeon and I agree that a forearm access is best for my treatment to save other sites for future use.The vein in your upper arm is at least 2.0 millimeters wide.I am under 18 years old.I am over 18 and have chosen hemodialysis for my kidney failure.
Research Study Groups:
This trial has the following groups:- Group 1: surgAVF
- Group 2: endoAVF
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.
Is the age limit for this research experiment restricted to 35 or older?
"Participants must meet the age criteria, which is 18 and above until 99 years old."
Answered by AI
Is this study looking for additional participants at the moment?
"As per clinicaltrials.gov, this medical study is not presently searching for participants; the initial post was dated February 1st 2023 and it has been recently updated on December 8th 2022. Nonetheless, there are 610 other experiments currently looking for volunteers."
Answered by AI
Can I join the roster of volunteers for this clinical experiment?
"This clinical trial needs 90 end-stage renal disease (ESRD) patients in the age group of 18 to 99 who are currently undergoing hemodialysis. The applicants must possess an arm vein diameter greater or equal than 2mm, a radial artery adjacent vein proximity not exceeding 1.5 mm and target vessels with diameters both over 2mm and no more than 2mm apart from each other as evaluated by ultrasound preprocedurally."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger