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Using automated ultrasound to assess arteriovenous fistula maturation

Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial

NA · Sonavex, Inc. · NCT06190717

This study tests if using a special ultrasound system can help people with end-stage kidney disease get their dialysis access ready faster than the usual care.

Quick facts

PhaseNA
Study typeInterventional
Enrollment304 (estimated)
Ages18 Years to 84 Years
SexAll
SponsorSonavex, Inc. (industry)
Locations21 sites (Dothan, Alabama and 20 other locations)
Trial IDNCT06190717 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of the EchoMark®/EchoSure® System for monitoring the maturation of arteriovenous fistulas (AVFs) in patients with end-stage renal disease. It is a prospective, multi-center, randomized trial that compares biweekly ultrasound assessments against standard care to determine if this approach can reduce the time to clinical maturation of AVFs. Participants will be monitored closely to assess the performance of the ultrasound system in facilitating timely dialysis access.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 with end-stage renal disease who are preparing for arteriovenous fistula creation.

Not a fit: Patients who are not candidates for arteriovenous fistula creation or those with a life expectancy of less than 18 months may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to faster maturation of arteriovenous fistulas, improving access to dialysis for patients with end-stage renal disease.

How similar studies have performed: Other studies utilizing ultrasound for vascular assessments have shown promise, suggesting that this approach may be beneficial, although this specific methodology is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 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.
* Subjects with an existing fistula or graft.
* Subjects who are anticipated to convert to peritoneal dialysis or undergo a transplant within 6 months.
* Subjects who are pregnant, planning on becoming pregnant, or are breast feeding.

Where this trial is running

Dothan, Alabama and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Diabetes, End Stage Renal Disease

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.