Impact of a Tunneled Hemodialysis Catheter With Endexo® Technology on Catheter Dysfunction Compar… (NCT07655544) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Impact of a Tunneled Hemodialysis Catheter With Endexo® Technology on Catheter Dysfunction Compared With Historical Catheter Dysfunction Data in Standard Catheters
Austria50 participantsStarted 2026-08-01
Plain-language summary
There is evidence that central venous catheters made of the permanent and non-eluting integral polymer Endexo® are more resistant to intraluminal thrombosis. This has a direct reducing effect on catheter malfunctions. Indirectly, due to reduced handling of the dysfunctional catheter, this may lead to a diminished rate of catheter related infections. Since catheter malfunctions and infections represent leading complications in a dialysis population, dialysis catheters produced with Endexo® technology have the potential to have beneficial clinical effects. In addition to improving patient outcomes, this could also reduce overall costs. In this pilot study the tunneled hemodialysis catheter BioFlo Duramax with Endexo® technology (Merit Medical, Utah, USA) will be compared with historical catheter dysfunction rates in standard tunneled dialysis catheters (silicone or polyurethane) in chronic dialysis population.
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:
* Adult patients aged greater than 18 years
* Written informed consent
* Requirement for hemodialysis using a tunneled dialysis catheter
Exclusion Criteria:
* Children aged less than 18 years
* Uncontrolled infection; defined as positive blood culture in the past seven days before catheter insertion and/ or elevated C-reactive protein \[CRP \>5 mg/dl (normal \<0.5 mg/dl)\] at screening
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 is comparing a new catheter using Endexo® technology against historical data from standard catheters rather than running a head-to-head comparison with patients side by side — does that study design give us enough reliable information to know if the new catheter is actually better for someone in my situation?
2Since this trial hasn't started recruiting yet, how long might it realistically be before I could even have a chance to participate, and is waiting for it a reasonable option given where my kidney disease is right now?
3The trial is focused on reducing catheter dysfunction — things like blockages and infections — but how does my specific history with vascular access problems affect whether a catheter with this new technology might be worth trying versus other access options like a fistula or graft?
4Because this is listed as Phase NA, what does that tell us about how much safety and effectiveness data already exists for the Endexo® technology, and are there any known risks specific to this catheter design I should understand before considering it?
5If I don't join this trial, what are the current standard options for tunneled hemodialysis catheters, and how do their track records on dysfunction and infection compare to what this new catheter is hoping to achieve?
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
Catheter dysfunction
Timeframe: From enrollment to the end of treatment at 6 months