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New ultrasound device aims to speed up dialysis access healing

NCT ID NCT06190717

Disease control Sponsor: Sonavex, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a device called EchoMark/EchoSure that is implanted during fistula surgery for dialysis patients. The device uses automated ultrasound to monitor healing every two weeks. The goal is to see if it helps the fistula mature faster and reduces the need for additional procedures. About 304 adults with kidney failure and diabetes are being enrolled.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
EchoMark/EchoSure device
What this could lead to
If successful, this device could help dialysis patients get their fistula ready for use faster, reducing the need for extra procedures.
What could go wrong
This is a relatively early-stage device trial with 304 participants. The device may not significantly speed up maturation, and there are risks like implant migration or infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 304 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 84 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease diabetes mellitus end stage renal failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes End-stage renal disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    20 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AKDHC Center Tucson

    RECRUITING

    Tucson, Arizona, 85754, United States

  • AKDHC Medical Research Services

    RECRUITING

    Phoenix, Arizona, 85012, United States

  • Aqua Research Institute Llc

    RECRUITING

    Houston, Texas, 77058, United States

  • Atrium Health

    RECRUITING

    Concord, North Carolina, 28025, United States

  • Baylor Scott & White Heart and Vascular Hospital

    RECRUITING

    Dallas, Texas, 75226, United States

  • Boston Medical Center

    RECRUITING

    Boston, Massachusetts, 02118, United States

  • Capital Medical Center

    RECRUITING

    Pennington, New Jersey, 08534, United States

  • Fresenius Vascular Care Memphis MSO

    TERMINATED

    Memphis, Tennessee, 38115, United States

  • Galen Medical Group

    RECRUITING

    Chattanooga, Tennessee, 37421, United States

  • HealthQare Associates

    RECRUITING

    Arlington, Virginia, 22201, United States

  • Kansas Nephrology Research Institute

    RECRUITING

    Wichita, Kansas, 67214, United States

  • MSU Health Care Heart and Vascular

    RECRUITING

    Lansing, Michigan, 48910, United States

  • Medical University of South Carolina Health Orangeburg

    RECRUITING

    Orangeburg, South Carolina, 29118, United States

  • Northwell Health

    RECRUITING

    New Hyde Park, New York, 11042, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Orlando Health Heart and Vascular Institute

    RECRUITING

    Orlando, Florida, 32806, United States

  • Physicians Care of Virginia

    RECRUITING

    Roanoke, Virginia, 24014, United States

  • Prisma Health

    RECRUITING

    Greenville, South Carolina, 29605, United States

  • Sentara Health

    RECRUITING

    Virginia Beach, Virginia, 23454, United States

  • Southwest Kidney Institute

    RECRUITING

    Phoenix, Arizona, 85004, United States

  • Trinity Research Group

    RECRUITING

    Dothan, Alabama, 36301, United States

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