🏛️ Verified NIH Record • Updated 2026-04-06
Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial (NCT06190717)
🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Sonavex, Inc.
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (11 items) and avoid the listed exclusions (15 items).
Location: Trinity Research Group — Dothan, Alabama
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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.
- Subject who is immunocompromised or immunosuppressed.
- Subject has had three previous failed AV fistulae for hemodialysis access.
- Subjects expecting to undergo major surgery within 60 days from the EchoMark implantation.
- Known or suspected active infection on the day of the index procedure.
- 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 with diagnosed bleeding disorder, thrombocytopenia (platelet count \<50,000), hypercoagulability, and history of recurrent deep vein thrombosis not related to AV access.
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (21 Sites)
- 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
- Northwestern University — Chicago, Illinois
- Kansas Nephrology Research Institute — Wichita, Kansas
- Boston Medical Center — Boston, Massachusetts
- MSU Health Care Heart and Vascular — Lansing, Michigan
- Capital Medical Center — Pennington, New Jersey
- Northwell Health — New Hyde Park, New York
- Atrium Health — Concord, North Carolina
- Prisma Health — Greenville, South Carolina
- Medical University of South Carolina Health Orangeburg — Orangeburg, South Carolina
- Galen Medical Group — Chattanooga, Tennessee
- Fresenius Vascular Care Memphis MSO — Memphis, Tennessee
- Baylor Scott & White Heart and Vascular Hospital — Dallas, Texas
- Aqua Research Institute Llc — Houston, Texas
- HealthQare Associates — Arlington, Virginia
- Physicians Care of Virginia — Roanoke, Virginia
- Sentara Health — Virginia Beach, Virginia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.