Study Summary
This trial will look at how well the Ellipsys Vascular Access System works in people who need an AV fistula.
- Arteriovenous Fistula
- End-Stage Renal Disease
- End-Stage Kidney Disease
- Arteriovenous Fistulas
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 4 Secondary · Reporting Duration: 12 months post-procedure
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Ellipsys Vascular Access System
1 of 1
Experimental Treatment
134 Total Participants · 1 Treatment Group
Primary Treatment: Ellipsys Vascular Access System · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 80 · All Participants · 14 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
Does the research team consider minors for enrollment in this trial?
"Participants in this medical experiment must be under 80 years old and of legal age." - Anonymous Online Contributor
What goals is this endeavor hoping to accomplish?
"This trial intends to measure Early Occlusion Rate at 7 days post-intervention as its principal objective over a timeframe of 12 months. Secondary objectives include Primary Patency Through 12 Months Post-AVF Creation, Assisted Primary Patency Through 12 Months Post-AVF Creation, and the Secondary Procedures Rate which records interventions aimed at maturing or sustaining the AVF's flow per person year." - Anonymous Online Contributor
Are there any American locations currently undergoing this clinical experiment?
"Both The Vascular Care Group in Hyannis, Massachusetts and Yale University in New Haven, Connecticut are participating sites for this research endeavour. Rush University Medical Center located in Chicago is also aiding with the study's progression along with 6 other medical centres." - Anonymous Online Contributor
How many participants have been accepted into this experiment?
"Indeed, clinicaltrials.gov shows that this research initiative, initially posted on April 13th 2021, is actively enrolling participants. A total of 134 individuals must be recruited from 6 different medical sites." - Anonymous Online Contributor
Is this research currently enrolling volunteers?
"According to clinicaltrials.gov, this research is still recruiting participants who meet the criteria stated in the initial post of April 13th 2021 and updated on October 6th 2022." - Anonymous Online Contributor
May I be part of this investigation?
"This clinical trial seeks to enrol 134 individuals who are aged between 18 and 80, have been diagnosed with End-Stage Renal Disease (ESRD) or Chronic Kidney Disease on hemodialysis, and can live for at least a year. Applicants must possess an arterial lumen of ≥2.0 mm in the target area along with adequate collateral perfusion as established by Barbeau Test; be medically qualified for upper extremity autogenous AV fistula formation per institutional guidelines/clinical judgement; demonstrate sufficient quality vein & radial artery based on preoperative assessment; display an adjacent vein diameter of ≥2.0 mm at" - Anonymous Online Contributor