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New treatment option for End Stage Renal Disease
Official title Xeltis Hemodialysis Access (aXess) Conduit: aXess-E Study
ClinicalTrials.gov ID: NCT06329310
What this study is testing
- What it's testing
- A prospective, single arm, non-randomized feasibility study to confirm the safety and performance of the Xeltis Hemodialysis Access conduit, aXess-E, in subjects older than 18 years with end-stage renal disease, who plan to undergo hemodialysis for at least the first 6 months after study access creation.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people with end-stage renal disease (ESRD) who require placement of an Arteriovenous Graft (AVG) in the upper extremity to start or maintain...
- At least 18 years of age at screening
- Suitable anatomy (e.g. a target vein with a minimum diameter of 5mm) for the implantation of an aXess-E conduit
- The patient has been informed about the nature of the study, understands and agrees to its provisions, and has personally provided written informed...
- The patient has been informed and agrees to pre- and post- procedure follow-up
You likely can't join if
- History or evidence of severe cardiac disease (New York Heart Association (NYHA) Functional Class IV and/or Ejection Fraction (EF) \<25%), myocardial...
- Uncontrolled or poorly controlled diabetes
- Abnormal blood values that could influence patient recovery and or/ conduit hemostasis
- Reduced liver function, defined as: \>2x the upper limit of normal for serum bilirubin, International Normalized Ratio (INR) \>1.5 or prothrombin...
- Any active local or systemic infection
- Known heparin-induced thrombocytopenia
See the full eligibility criteria
- people with end-stage renal disease (ESRD) who require placement of an Arteriovenous Graft (AVG) in the upper extremity to start or maintain hemodialysis therapy
- At least 18 years of age at screening
- Suitable anatomy (e.g. a target vein with a minimum diameter of 5mm) for the implantation of an aXess-E conduit
- The patient has been informed about the nature of the study, understands and agrees to its provisions, and has personally provided written informed consent
- The patient has been informed and agrees to pre- and post- procedure follow-up
- Life expectancy of at least 12 months
- History or evidence of severe cardiac disease (New York Heart Association (NYHA) Functional Class IV and/or Ejection Fraction (EF) \<25%), myocardial infarction within six months of study enrolment, ventricular...
- Uncontrolled or poorly controlled diabetes
- Abnormal blood values that could influence patient recovery and or/ conduit hemostasis
- Reduced liver function, defined as: \>2x the upper limit of normal for serum bilirubin, International Normalized Ratio (INR) \>1.5 or prothrombin time (PT) \>18 seconds
- Any active local or systemic infection
- Known heparin-induced thrombocytopenia
- Known active bleeding disorder and/or any coagulopathy or thromboembolic disease
- Allergies to study device (nitinol) or agents/medication, such as contrast agents or aspirin, that can't be controlled medically
- Anticipated renal transplant within 6 months
- Known or suspected central vein obstruction on the side of planned conduit implantation
- Previous dialysis access conduit in the operative limb unless the aXess-E conduit can be placed more proximally than the previous failed conduit
- Previous enrolment in this study
- Subject is participating in another study
- Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
- Any other condition which, in the judgement of the investigator would preclude adequate evaluation for the safety and performance of the study conduit Intra-operative exclusion criteria: 1\. Unsuitable anatomy to...
The study team makes the final eligibility decision.
Where it's taking place
- Lisbon, Portugal
- Belgrade, Serbia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lisbon, Portugal; Belgrade, Serbia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.