Recruiting

Observational StudyMaturation of Arteriovenous Fistula With Automated Sonography Assessments Trial

Sponsor:

Sonavex, Inc.

Code:

NCT06190717

Conditions

Diabetes

End Stage Renal Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

EchoMark/EchoSure

Standard of Care

Study Details

Brief summary:

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.

Conditions

Diabetes

End Stage Renal Disease

Study ID

NCT06190717

Start date

Feb 21, 2024

Status verified date

Jun, 2025

Completion date

Feb 1, 2027

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

304 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Diagnostic Arm

All subjects will have the EchoMark implanted. Subjects will be assessed every 2 weeks (+/- 1 week) (but no more frequently than weekly) with the EchoSure system until fistula maturation occurs and/or permanent access use is achieved.

active comparator: Standard of Care

Subjects will be evaluated per KDOQI guidelines (with physical examination at approximately 2 weeks (+/- 1 week) and between 4 and 6 weeks (+/- 1 week)). If evaluation yields abnormal findings, subjects will receive a Duplex ultrasound assessment (DUS). All SOC Arm subjects will be followed per the institution's standard of care until fistula maturation occurs and/or permanent access use is achieved but no more frequently than once per month.

Interventions

EchoMark/EchoSure

Subjects assigned to the Diagnostic Arm will have the EchoMark implanted at the time of AVF creation. The subject will return every 2 weeks for a follow-up assessment to include an EchoSure scan until fistula maturation and/or permanent access use is achieved. The EchoSure scans are to be reviewed by the investigator(s) or delegated study staff and aid in the determination when a further assessment, including a physical exam, is required to determine cannulation clearance or if an intervention(s) may be required to prevent failure of fistula maturation. All physical exams will include assessing the fistula for bruit and thrill. The subject's medical history will be reviewed at each visit and will include all interventions, cannulation attempts, and adverse event reporting.

Standard of Care

Subjects are assessed using standard of care per KDOQI guidelines, which includes a physical exam at the 2-week follow-up visit and at the 4-6-week follow-up visit. All follow-up visits will include an assessment of adverse events and medical history review to include all interventions, cannulation attempts, and laboratory results. If evaluation yields an abnormal finding, subjects will undergo a Duplex ultrasound assessment and treatment under the institution's standard of care. All SOC Arm subjects will be followed per the institution's standard of care until fistula maturation occurs and/or permanent access use is achieved but no more frequently than once per month.

Primary outcome measure

Primary Safety Endpoint [ Time Frame: 6 months ]
Primary Effectiveness Endpoint [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Katy Feeny

443-862-2024 kfeeny@sonavex.com

Locations

Trinity Research Group

Recruiting

Dothan, Alabama, United States, 36301

Principal Investigator:

Jason Beaver, MD

Southwest Kidney Institute

Recruiting

Phoenix, Arizona, United States, 85004

Principal Investigator:

Umar Waheed, MD

AKDHC Medical Research Services

Recruiting

Phoenix, Arizona, United States, 85012

Principal Investigator:

S Wang, MD

AKDHC Center Tucson

Recruiting

Tucson, Arizona, United States, 85754

Contacts

A Munoz

520-622-3569 amgallego@akdhc.com

Principal Investigator:

Z Yang, MD

Orlando Health Heart and Vascular Institute

Recruiting

Orlando, Florida, United States, 32806

Principal Investigator:

G Castaneda, MD

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Principal Investigator:

V Rohan, MD

Kansas Nephrology Research Institute

Recruiting

Wichita, Kansas, United States, 67214

Contacts

A Anderson

316-262-2045 aanderson@researchmgmt.com

Principal Investigator:

Dennis Ross, MD

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Principal Investigator:

J Siracuse, MD

MSU Health Care Heart and Vascular

Recruiting

Lansing, Michigan, United States, 48910

Principal Investigator:

Jordan Knepper, MD

Capital Medical Center

Recruiting

Pennington, New Jersey, United States, 08534

Principal Investigator:

Christine Lotto, MD

Northwell Health

Recruiting

New Hyde Park, New York, United States, 11042

Principal Investigator:

Yana Etkin, MD

Atrium Health

Recruiting

Concord, North Carolina, United States, 28025

Principal Investigator:

Christopher Mitromaras, MD

Prisma Health

Recruiting

Greenville, South Carolina, United States, 29605

Principal Investigator:

Sagar Gandhi, MD

Medical University of South Carolina Health Orangeburg

Recruiting

Orangeburg, South Carolina, United States, 29118

Principal Investigator:

Mark London, MD

Galen Medical Group

Recruiting

Chattanooga, Tennessee, United States, 37421

Principal Investigator:

S Phade, MD

Baylor Scott & White Heart and Vascular Hospital

Recruiting

Dallas, Texas, United States, 75226

Principal Investigator:

Stephen Hohmann, MD

Aqua Research Institute Llc

Recruiting

Houston, Texas, United States, 77058

Principal Investigator:

Rupal Patel, MD

HealthQare Associates

Recruiting

Arlington, Virginia, United States, 22201

Contacts

M Lewandowski

703-908-0800 Magdalena.Lewandowski@AzuraCare.com

Principal Investigator:

Homayoun Hashemi, MD, FACS, RVT, RPVI

Physicians Care of Virginia

Recruiting

Roanoke, Virginia, United States, 24014

Principal Investigator:

Ryan Evans, MD

Sentara Health

Recruiting

Virginia Beach, Virginia, United States, 23454

Principal Investigator:

Samuel Steerman, MD

More Information

Sponsor

Sonavex, Inc.

Last update posted

Apr 13, 2026

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sonavex, Inc. on 2026-04-13.