Tests an ultrasound device for dialysis access maturation in adults with kidney failure
Compares an ultrasound device with standard care to help fistulas mature in kidney failure patients.
Plain-language title generated from the registry record
Registry title: Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial
Key facts
- Where
- Arlington, Boston, Chattanooga, Chicago, Columbia, Concord, Dallas, Dothan, Greenville, Houston, Lansing, Memphis, New Hyde Park, Orangeburg, Orlando, Pennington, Phoenix, Roanoke, Sarasota, Tucson, Virginia Beach, and Wichita, United StatesSee the 23 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 84 years old?
Source: NCT06190717, who can take part
Where in United States
- HealthQare AssociatesArlington, United StatesTaking people
- Boston Medical CenterBoston, United StatesTaking people
- Galen Medical GroupChattanooga, United StatesTaking people
- Northwestern UniversityChicago, United StatesTaking people
- Vascular Care of South CarolinaColumbia, United StatesTaking people
- Atrium HealthConcord, United StatesTaking people
- Baylor Scott & White Heart and Vascular HospitalDallas, United StatesTaking people
- Trinity Research GroupDothan, United StatesTaking people
- Prisma HealthGreenville, United StatesTaking people
- aQua Research Institute, LLCHouston, United StatesTaking people
- MSU Health Care Heart and VascularLansing, United StatesNo longer taking part
- Fresenius Vascular Care Memphis MSOMemphis, United StatesNo longer taking part
- Northwell HealthNew Hyde Park, United StatesTaking people
- Medical University of South Carolina Health OrangeburgOrangeburg, United StatesTaking people
- Orlando Health Heart and Vascular InstituteOrlando, United StatesTaking people
- Capital Medical CenterPennington, United StatesTaking people
- AKDHC Medical Research ServicesPhoenix, United StatesTaking people
- Southwest Kidney InstitutePhoenix, United StatesTaking people
- Physicians Care of VirginiaRoanoke, United StatesTaking people
- Sarasota Medical Health Care SystemSarasota, United StatesTaking people
- AKDHC Center TucsonTucson, United StatesTaking people
- Sentara HealthVirginia Beach, United StatesTaking people
- Kansas Nephrology Research InstituteWichita, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sonavex, Inc.
- Trial code
- NCT06190717
- Record updated
- 28 October 2026
- Original description
This is a prospective, multi-center, two-arm, randomized trial to quantify the performance of the EchoMark®/EchoSure® System for AVF diagnostic ultrasound when used under a protocol of biweekly use for assessing fistula maturation and reducing time to Clinical Maturation.Read full original descriptionShow less
Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial
This is a prospective, multi-center, two-arm, randomized trial to quantify the performance of the EchoMark®/EchoSure® System for AVF diagnostic ultrasound when used under a protocol of biweekly use for assessing fistula maturation and reducing time to Clinical Maturation.
Inclusion: Males or non-pregnant, non-breastfeeding females ≥ 18 years of age but < 85 years of age at the time of informed consent; Subject is able and willing to provide written informed consent prior to receiving any non-standard of care, protocol specific procedures; Subject is willing and capable of complying with all required follow-up visits; Subject and/or Care Team agree that the distance and transportation resources from the patient's home to the clinic are reasonable for study participation and compliance; Subject has an estimated life expectancy > 18 months; Subject is ambulatory (cane or walker are acceptable); CKD Stage 5 (eGFR less than 10) or ESRD subjects presenting for upper arm autologous arteriovenous fistula creation that is not transposed for hemodialysis access; Subjects who are currently on dialysis through a CVC or who imminently require dialysis (GFR <10); Vein diameter ≥ 2.5 mm at the antecubital fossa per vein mapping; Artery diameter ≥ 2.5 mm per vein mapping; Subject is not participating in another investigational clinical trial that has not met its primary end point. Participation in post-market registry is acceptable.
Exclusion: Subject has had three previous failed AV fistulae for hemodialysis access; Subjects expecting to undergo major surgery within 60 days from the EchoMark implantation; Subjects who had infection(s) in the 30-day window prior to EchoMark placement to reduce the likelihood of partially treated infections that can seed the device and fistula; Subjects who are anticipated to convert to peritoneal dialysis or undergo a transplant within 6 months; CKD Stage 1-4 or subjects that do not require upper arm autologous arteriovenous fistula creation for hemodialysis access; Subject has history of Steal Syndrome; Known or suspected active infection on the day of the index procedure; Subjects with active malignancy; Subjects with a history of poor compliance with the dialysis protocol; Subjects with a known or suspected allergy to any of the device materials; Subjects with an existing fistula or graft; Subjects with diagnosed bleeding disorder, thrombocytopenia (platelet count <50,000), hypercoagulability, and history of recurrent deep vein thrombosis not related to AV access; Subject who is immunocompromised or immunosuppressed; Subjects who are pregnant, planning on becoming pregnant, or are breast feeding.