Plain-English translation of NCT07211035 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.
This study evaluates the Amplifi™ Vein Dilation System, a medical device designed to gently stretch veins before surgery to create dialysis access for people with end-stage kidney disease. The device works by pushing controlled blood flow through a vein for 24 to 72 hours before the surgical procedure. Researchers want to know if this pre-treatment helps veins grow large enough to work better for dialysis long-term.
Many people with end-stage kidney disease need dialysis, which requires special blood vessel connections (called fistulas) to be created surgically in the arm. Unfortunately, some veins are too small or don't mature properly after surgery, making the fistula unusable. This trial tests whether stretching the vein beforehand with the Amplifi device can prevent these failures.
You likely qualify if…
You likely don't qualify if…
If you join this trial, you will first have the Amplifi device placed through a catheter (a thin tube) in your neck for 24 to 72 hours to gently stretch your vein. After this treatment, you will have surgery to create your dialysis fistula. You will then return for follow-up visits and ultrasound imaging at 2 weeks and beyond to see how well your fistula is developing. Some participants will receive the device treatment, while others (in the control group) will have surgery without the pre-treatment, so doctors can compare results.
AI-generated summary from trial data · Jul 11, 2026 · Not medical advice
United States