Ellipsys Vascular Access System Post Market Surveillance (PS) Study (NCT04484220) | Clinical Trial Compass
CompletedNot Applicable
Ellipsys Vascular Access System Post Market Surveillance (PS) Study
United States142 participantsStarted 2021-04-13
Plain-language summary
The proposed clinical study is a prospective, non-randomized, multi-center, single-arm, observational, post-market surveillance (PS) study of the Ellipsys Vascular Access System in subjects eligible for arteriovenous (AV) fistula.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or non-pregnant female ≥ 18 years of age and ≤ 80 years of age
. Life expectancy of at least one year, in the investigator's opinion
. Diagnosed with ESRD or chronic kidney disease on hemodialysis.
. Patients deemed medically eligible for upper extremity autogenous AV fistula creation, per institutional guidelines and/or clinical judgment
. Adequate quality vein based on pre-operative assessment
. Adjacent vein diameter of ≥2.0 mm at target anastomosis site
. Confirmed clinically significant outflow
. Adequate quality radial artery based on pre-operative assessment
Exclusion criteria
. Pre-existing ipsilateral vascular disease interfering with the study procedure or potentially confounding the study results including:
. Documented or suspected central venous stenosis (≥ 50%) or
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study used a device called the Ellipsys system to create an AV fistula without open surgery — can you explain how that approach compares to the traditional surgical method, and whether either option might be better for my situation?
2The trial tracked whether fistulas stayed open and working over 12 months — do you know what the results showed, and how does that compare to what I might expect from a standard surgically created fistula?
3One of the things they measured was early blockage within the first 7 days after the fistula was made — what signs should a patient watch for in that early window, and how quickly would that need to be addressed?
4Since this study is now completed and this was a post-market surveillance study rather than an early-phase trial, does that mean the Ellipsys device is already in routine use, and is it something available at your facility or would I need to go elsewhere?
5Given that my kidneys are failing and I may need dialysis, how does my doctor weigh the timing of fistula creation against other access options like a graft or catheter, and would a minimally invasive approach like this one even be on the table for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cumulative Patency Through 12 Months Post-AVF Creation
Timeframe: 12 months post-procedure
2
Early Occlusion Rate at 7 Days
Timeframe: 7 days post-procedure
3
Study Related Serious Adverse Event (SAE) Rate Through 12 Months
. Vascular disease at the radial artery / adjacent vein site
. Prior vascular surgery at or proximal (central) to the AVF target site interfering with AVF maturation or other ipsilateral surgery that could potentially confound the study results such as prior axillary dissection or mastectomy
. History of steal syndrome from a previous surgical ipsilateral hemodialysis vascular access which required intervention or abandonment
. Systolic pressures \< 100 mg Hg at the time of screening
. Suspected or confirmed skin disease at the skin entry site