Access Cannulation Trial II (NCT05490225) | Clinical Trial Compass
RecruitingNot Applicable
Access Cannulation Trial II
United States100 participantsStarted 2025-04-23
Plain-language summary
This is a pivotal, interventional, prospective, single-arm, open-label, multi-site clinical investigation intended to support FDA clearance of the study device based on the safety and efficacy of the device in cannulating arteriovenous fistulas (AVFs) for hemodialysis procedures.
Who can participate
Age range
18 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
. The subject's AVF is deemed uncannulatable because:
. The subject's anticipated cannulation zone(s) is/are \>6mm in depth from the surface of the skin to the anterior wall of the access vein as confirmed by ultrasound within 8 weeks prior to device implantation (each zone, Arterial/Pull and Venous/Push, shall be assessed independently of one another for device placement):
. The subject's dialysis unit (which includes an experienced cannulator) attests that repeated cannulation is not achievable in their clinic due to one of the following:
. The access surgeon caring for the subject attests that the device is likely to be at least equivalent to other methods (such as venous transposition or suction-assisted lipectomy) that could make the AVF easier to access and reduce risk of cannulation infiltrations.
. The subject has either a radio-cephalic, brachio-cephalic or transposed brachio-basilic fistula.
Exclusion criteria
. The subject's access vein is \>15mm in depth at either cannulation zones as measured by ultrasound within 8 weeks prior to device implantation.
. Both bidimensional measurements in the subject's access vein have a diameter of \<4mm, taken with a tourniquet in place or through manual compression to the outflow, as measured by ultrasound within 8 weeks prior to device implantation (cannulation zone specific - one zone does not affect the other's eligibility).
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
To demonstrate the effectiveness of the study device in facilitating cannulation of arteriovenous fistulas (AVFs) for hemodialysis.
. The subject has a flow rate of \<550mL/min in the inflow artery proximal to the arterial anastomosis as measured by ultrasound within 8 weeks prior to device implantation.
. The subject does NOT have a prescription to receive maintenance hemodialysis at least 2 times per week.
. The subject's life expectancy is \<1 year per the Investigator.
. The subject does NOT have a signed and dated consent form.
. The AVF is a non-transposed basilic or brachial vein outflow AVF.
. The subject has high flow rates placing them at risk for heart failure and death at the discretion of the Investigator.