The goal of this clinical trial is to determine whether the study device can assist the cannulator with placing two needles during cannulation required to initiate dialysis treatment.
Males or females with end-stage kidney disease who are 18 and older and not pregnant or breastfeeding can be included in the study.
The main question it aims to answer is:
Can the study device guide the cannulator to the arteriovenous fistula (AVF) or arteriovenous graft (AVG) and assist the cannulator with needle insertion into the AVF or AVG for dialysis cannulation?
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:
* Males or non-pregnant, non-breastfeeding females ≥ 18 years of age
* Presence of an AVG/AVF access site in the forearm or upper arm
* AVF is actively used for dialysis treatment
* AVF diameter is between 8 mm and 12mm, confirmed by ultrasound
* AVF is ≤6 mm below the surface of the skin, confirmed by ultrasound
* Able to report their pain using a validated pain scale.
* Able and willing to provide written informed consent.
Exclusion Criteria:
* Presence of known (pseudo-)aneurysms, stenosis, thrombosis or stents in the AVF/AVG access site
* Presence of a condition or impediment that may interfere with ultrasound imaging
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 trial tested a guided needle insertion device for accessing fistulas and grafts during hemodialysis — given that it's now completed, has my doctor seen any of the results, and what do they suggest about whether this kind of technology might eventually be available at our dialysis center?
2The trial measured whether successful cannulation could be achieved within three attempts — how does my current cannulation experience compare to that benchmark, and is difficult access something my care team is actively trying to address for me?
3Since this study is finished and was listed as 'Phase NA,' meaning it was likely a device feasibility or usability study rather than a full drug trial, what level of evidence would my doctor need to see before they'd feel confident recommending a guided insertion tool for my specific fistula or graft?
4For patients who struggle with painful or repeated needle sticks during dialysis, what options does my doctor currently have available to make cannulation easier or less traumatic, while we wait to see if technologies like this become more widely adopted?
5If the results from this trial eventually support wider use of guided needle insertion, how would my doctor decide whether it's appropriate for my type of vascular access — whether that's an AVF or an AVG — given that both were included in this study?
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
Proportion of investigational device cannulations in which successful cannulation of the AVF/AVG is achieved within a maximum of three attempts, confirmed by blood flashback and ability to proceed with dialysis.