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 range18 Years
SexALL
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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).
✕. 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.
What they're measuring
1
To demonstrate the effectiveness of the study device in facilitating cannulation of arteriovenous fistulas (AVFs) for hemodialysis.