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Ellipsys Vascular Access System for Arteriovenous Fistula
Study Summary
This trial will look at how well the Ellipsys Vascular Access System works in people who need an AV fistula.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I currently have an active infection.Your vein is very close to your radial artery, as shown by an ultrasound test before the procedure.I've had surgery near the planned site for my arteriovenous fistula that could affect its development.I am immunocompromised due to a condition or medication like sirolimus or high-dose Prednisone.I am scheduled for a kidney transplant within the next 6 months.The vein near the site of connection is at least 2.0 millimeters in diameter.I have swelling in the arm on the same side as my cancer.You have a confirmed significant blockage in the flow of something in your body.The artery at my surgery site is at least 2.0 mm wide.I have a bleeding or clotting disorder, or take medication that increases my bleeding risk.I am currently hospitalized or experiencing ongoing effects from COVID-19.I am between 18 and 80 years old and not pregnant.I had complications from a previous dialysis access surgery that needed fixing or was abandoned.I have a skin condition at the site where medical procedures are performed.Your blood pressure is lower than 100 mm Hg when measured.The doctor thinks you will live for at least one more year.I am considered fit for a specific type of dialysis access surgery in my arm, as per my doctor's judgment.My veins are considered good quality for surgery.My radial artery is in good condition according to a recent check.I do not have major blood vessel problems in the same side of my body as the study treatment.My radial artery and nearby vein are at least 2.0 mm wide where they connect.I have been diagnosed with end-stage renal disease or am on hemodialysis for chronic kidney disease.You have good blood flow in the arteries of your hand, shown by specific tests.The distance between the radial artery and a nearby vein is less than 1.5 millimeters, as measured by ultrasound before the procedure.
- Group 1: Ellipsys Vascular Access System
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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."
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."
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"
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