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Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial

This study is looking at how well a new device, the EchoMark/EchoSure System, helps doctors understand if an arteriovenous fistula (AVF) is maturing correctly. An AVF is a surgically created connection between an artery and a vein, often used for dialysis in people with End Stage Renal Disease or Diabetes. The study compares using this device every two weeks to standard care, which involves physical exams. Researchers want to see if the EchoMark/EchoSure System can help reduce the time it takes for an AVF to be ready for use. You may be able to join if you are between 18 and 84 years old, are not pregnant or breastfeeding, and are able to attend all study visits. The study aims to measure the safety and effectiveness of the device over 6 months. The current recruitment status is unclear.

Study design
This is a randomized study with two groups, aiming to enroll 304 participants. One group will use the EchoMark/EchoSure device, and the other will receive standard care.
What's involved
If you are in the device group, you will have the EchoMark implanted during AVF creation and return every two weeks for an EchoSure scan until your fistula is ready. If you are in the standard care group, you will have physical exams at 2 and 4-6 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety and effectiveness for 6 months after starting the study.

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NCT06190717

Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial

Recruiting
NAAges 18–84InterventionalTreatment
Sonavex, Inc.
~304 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:EchoMark/EchoSureStandard of Care

At a glance

Recruiting sites
20 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Safety Endpoint
Measured over 6 months
+1 more outcome measured

Conditions

Diabetes
End Stage Renal Disease

Explore related trials

Chronic Kidney Disease, Stage 5Diabetes Mellitus

Where it's being run

21 sites across 14 states
Arizona3
Virginia3
South Carolina2
Tennessee2
Texas2
Alabama1
Florida1
Illinois1

Who to contact

Katy Feeny
[email protected]
443-862-2024
Email the study team

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Eligibility criteria

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

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.

What this trial measures

  • Primary Safety Endpoint6 months

    Freedom from the following through 6 months as adjudicated by the CEC: 1. Clinically significant misplacement or migration of the EchoMark implant. 2. Vessel or tissue injury caused by the EchoMark implant procedure of the implant over time, requiring surgical intervention. 3. Infection of tissues surrounding the EchoMark implant requiring IV/ 4. Complication requiring explantation of the EchoMark implant.

  • Primary Effectiveness Endpoint6 months

    Time to clinical maturation