Recruiting

Testing a New Ultrasound Device to Monitor Fistula Development

Plain-English translation of NCT06190717 on ClinicalTrials.gov ↗ · Source last updated April 2026 · Translation generated June 2026 · 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.

What is this trial?

This trial is testing a device called the EchoMark/EchoSure System, which uses ultrasound to monitor how well an arteriovenous fistula develops after surgery. An arteriovenous fistula is a connection between an artery and a vein that allows people with kidney failure to receive dialysis. The trial compares using this new device every two weeks to monitor the fistula against the standard way doctors currently check fistula maturation.

When people with advanced kidney disease need dialysis, a healthy arteriovenous fistula is critical for treatment. However, not all fistulas mature properly, and doctors currently have limited ways to predict or catch problems early. This trial hopes that more frequent and precise ultrasound monitoring with the new device will help fistulas mature faster and reduce complications.

Do you qualify?

You likely qualify if…

you are between 18 and 85 years old
you have advanced kidney disease (Stage 5 chronic kidney disease or end-stage renal disease) and need dialysis or will need it soon
you are scheduled to have an upper arm arteriovenous fistula created for dialysis access
your arm veins and arteries are large enough (at least 2.5 mm diameter) to support a fistula
you can travel to the clinic for follow-up visits every two weeks and commit to the study timeline
you have a life expectancy of at least 18 months

You likely don't qualify if…

you have had three or more failed arteriovenous fistulas in the past
you have a history of steal syndrome (a complication where the fistula takes too much blood flow)
you have an active infection or had an infection in the past 30 days
you are immunocompromised or taking immunosuppressant medications
you are pregnant, planning to become pregnant, or breastfeeding

What participation looks like

If you join this trial, you will be randomly assigned to one of two groups. One group will receive the new EchoMark device implanted and have ultrasound checks every two weeks to monitor fistula maturation. The other group will follow standard care with physical exams and ultrasound only if doctors find problems. Both groups will be followed until your fistula is ready to use for dialysis, typically over several weeks to a few months.

AI-generated summary from trial data · Jun 12, 2026 · Not medical advice

Trial locations(21 sites)

United States

Trinity Research Group, Dothan, Alabama

Southwest Kidney Institute, Phoenix, Arizona

AKDHC Medical Research Services, Phoenix, Arizona

AKDHC Center Tucson, Tucson, Arizona

Orlando Health Heart and Vascular Institute, Orlando, Florida