Xeltis Hemodialysis Access Graft: aXess Pivotal Study
This study focuses on a new type of graft, called the Xeltis aXess graft, designed for people with severe kidney failure who need regular dialysis. Dialysis is a treatment that cleans the blood when the kidneys can no longer do their job. To do this, doctors often create a special access point, and this new graft is being tested as a way to do that. The study wants to find out if this graft is safe and effective in helping patients receive their dialysis treatments. It's for adults over 18 who are planning to have dialysis for at least six months after the graft is put in. Participants will be carefully monitored to see how the graft performs.
At a glance
What is this study about?
When your kidneys aren't working properly – a condition called end-stage renal disease – you often need a treatment called dialysis. Dialysis helps to filter your blood, doing the job your kidneys can no longer do. For dialysis to work, doctors need a good way to access your bloodstream, and this is usually done by creating a special connection under your skin, often in your arm.
This study is looking at a new option for this connection, called the Xeltis aXess graft. It's a special tube or conduit that doctors can place to create a stable and reliable access point for your dialysis treatments. The study aims to understand how safe and effective this new graft is for people needing dialysis. They want to see if it allows for successful dialysis and if it causes any problems.
By taking part, you'd be helping doctors learn more about this new graft. This research is important because finding better ways to create dialysis access can make a real difference in the lives of people who depend on dialysis for their health.
Key takeaways
- This study is testing a new graft for dialysis patients.
- It aims to check if the new graft is safe and works well.
- You must be over 18 and need dialysis for at least 6 months.
- Regular follow-up appointments will be needed after the graft is placed.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
This study is looking for adults aged 18 or over who have severe kidney disease and need dialysis. You would need to have suitable blood vessels in your arm for the graft to be put in, and you should be planning to have dialysis for at least six months after the graft is placed. You must also be able to understand the study and agree to take part, and be able to come for all the follow-up visits.
There are also some reasons why you might not be able to join. For example, if you have very severe heart problems, uncontrolled diabetes, or certain blood disorders, you wouldn't be eligible. Also, if you have certain infections, or allergies to the graft material or medicines used in the study that can't be managed, or if you are pregnant or breastfeeding, you wouldn't be able to take part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have severe kidney disease and need dialysis?
- Are you planning to have dialysis for at least 6 months?
- Do you have suitable blood vessels for the graft in your arm?
- Do you have any severe heart problems or uncontrolled diabetes?
What does participation involve?
If you decide to take part in this study, the Xeltis aXess graft will be surgically put into your arm to create your dialysis access. After the procedure, you'll have regular follow-up appointments. These visits will involve various tests and checks to make sure the graft is working well and that you are recovering properly. The study team will monitor your blood pressure, heart rate, and conduct blood tests and sometimes imaging scans to look at the graft. These visits are important for the researchers to collect information on how safe and effective the new graft is. You'll need to commit to these appointments for at least six months after the graft is placed, and possibly longer, to ensure all necessary information is gathered.
Potential risks and benefits
Locations (22)
- AZ Sint Jan BruggeVerified postcodeBruges, Belgium
- ZOL GenkVerified postcodeGenk, Belgium
- UZ GhentVerified postcodeGhent, Belgium
- Universitätsklinikum KölnVerified postcodeCologne, Germany
- LAIKO General Hospital of AthensVerified postcodeAthens, Greece
- University General Hospital of PatrasVerified postcodePátrai, Greece
- Ospedali Riuniti Torrette di AnconaVerified postcodeAncona, Italy
- Policlinico di BariVerified postcodeBari, Italy
- Policlinico di Sant'OrsolaVerified postcodeBologna, Italy
- Università degli studi di Padova / Azienda ospedaliera di PadovaVerified postcodePadova, Italy
- Universita degli studi dell'InsubriaVerified postcodeVarese, Italy
- Pauls Stradins Clinical University HospitalVerified postcodeRiga, Latvia
Common questions
What is end-stage renal disease?
It's when your kidneys have stopped working well enough on their own, and you need treatments like dialysis to help clean your blood.
What is a hemodialysis access graft?
It's a special connection, often put in your arm, that allows doctors to easily and safely connect you to the dialysis machine.
Will I have to pay to be part of the study?
No, you will not have to pay for the study treatment or assessments. This will be explained fully by the study team.
Can I leave the study at any time?
Yes, you are free to leave the study at any point, and it won't affect your ongoing medical care.
What does 'non-randomized' mean?
It means you won't be randomly assigned to different treatment groups, everyone in this study will receive the Xeltis aXess graft.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.