Chronic Kidney Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are a man or a woman (not pregnant or breastfeeding) between 18 and 84 years old at the time of signing the consent form.
• You are able and willing to sign a written consent form before any study-specific steps are taken.
• You are willing and able to attend all required follow-up appointments.
• You and/or your care team agree that travelling from your home to the clinic is manageable for the length of the study.
• Your doctors estimate you have a life expectancy of more than 18 months.
• You are able to walk, with or without a cane or walker.
• You have very advanced chronic kidney disease (stage 5) or kidney failure and are scheduled to have a specific type of blood vessel connection (called an arteriovenous fistula) created in your upper arm for kidney dialysis.
• You are currently on dialysis through a neck/chest catheter, or your kidney function has dropped to a level where dialysis will be needed very soon.
• The vein and artery in your upper arm area are large enough (at least 2.5 mm each), as confirmed by a vein mapping scan.
• You are not currently taking part in another research trial that has not yet reached its main goal.

Who may not be able to join:

• You have an earlier stage of chronic kidney disease (stages 1–4) or do not need the specific type of fistula described in this trial.
• You have a history of a condition called Steal Syndrome (where blood flow is diverted away from the hand, causing pain or damage) (confirm with trial site).
• You have a weakened immune system or are taking medication that suppresses your immune system.
• You have already had three previous arteriovenous fistulas that did not work.
• You are expected to have a major surgery within 60 days of the study device being placed.
• You have a known or suspected active infection on the day of the procedure.
• You had an infection in the 30 days before the device would be placed.
• You have a bleeding disorder, a low platelet count, a condition that causes your blood to clot too easily, or a history of recurring blood clots in deep veins (unrelated to dialysis access).
• You currently have an active cancer.
• You have a history of not following your dialysis treatment plan as required.
• You have a known or suspected allergy to any of the materials used in the study device.
• You already have a working fistula or a dialysis graft in place.
• It is expected that you will switch to a different type of dialysis (peritoneal dialysis) or receive a kidney transplant within 6 months.
• You are pregnant, planning to become pregnant, or are currently breastfeeding.

Important: Always verify eligibility with the trial site directly before applying.