Study of EchoMarkEchoSure System to Monitor and Improve Maturation of Arteriovenous Fistula for Hemodialysis in Adults

What this Trial Is About

Researchers are evaluating the EchoMarkEchoSure System for diagnostic ultrasound in patients with arteriovenous fistula AVF created for hemodialysis access. This randomized, multi-center trial aims to assess whether biweekly ultrasound assessments can better track fistula maturation and reduce the time until the fistula is ready for clinical use. The study involves adults with advanced kidney disease, including those on dialysis or approaching dialysis, who require upper arm AVF creation. Participants are divided into two groups. One group receives the EchoMark device implanted during fistula creation and undergoes EchoSure scans every two weeks to monitor fistula development until maturation or permanent access use. The other group follows the standard care protocol, including physical exams at about 2 weeks and 4 to 6 weeks post-surgery, with additional ultrasound assessments if abnormalities are detected. Both groups continue follow-up until fistula maturation or permanent access use, with visit frequency limits set by the study. During the study, participants will have regular assessments including physical exams, ultrasound scans, medical history reviews, and adverse event monitoring. Researchers will compare safety and effectiveness measures at 6 months, including ultrasound flow and size measurements, hospitalization rates, and costs. The study also tracks events related to fistula use and catheter removal. Participation may last several months, with ongoing monitoring to measure outcomes and device performance.

Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial