Back to Trials
NCT06190717NARecruiting

Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial

Sonavex, Inc.

Start Date

2/21/2024

Completion Date

2/1/2027

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.

Eligibility Criteria

Age Range: 18 years to 84 years

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.

Interventions

DEVICE

EchoMark/EchoSure

PROCEDURE

Standard of Care

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

DiabetesEnd Stage Renal Disease

Locations

Trinity Research Group

Dothan, Alabama 36301

United States

Southwest Kidney Institute

Phoenix, Arizona 85004

United States

AKDHC Medical Research Services

Phoenix, Arizona 85012

United States

AKDHC Center Tucson

Tucson, Arizona 85754

United States

Orlando Health Heart and Vascular Institute

Orlando, Florida 32806

United States

Northwestern University

Chicago, Illinois 60611

United States

Kansas Nephrology Research Institute

Wichita, Kansas 67214

United States

Boston Medical Center

Boston, Massachusetts 02118

United States

MSU Health Care Heart and Vascular

Lansing, Michigan 48910

United States

Capital Medical Center

Pennington, New Jersey 08534

United States

Northwell Health

New Hyde Park, New York 11042

United States

Atrium Health

Concord, North Carolina 28025

United States

Prisma Health

Greenville, South Carolina 29605

United States

Medical University of South Carolina Health Orangeburg

Orangeburg, South Carolina 29118

United States

Galen Medical Group

Chattanooga, Tennessee 37421

United States

Fresenius Vascular Care Memphis MSO

Memphis, Tennessee 38115

United States

Baylor Scott & White Heart and Vascular Hospital

Dallas, Texas 75226

United States

Aqua Research Institute Llc

Houston, Texas 77058

United States

HealthQare Associates

Arlington, Virginia 22201

United States

Physicians Care of Virginia

Roanoke, Virginia 24014

United States

Sentara Health

Virginia Beach, Virginia 23454

United States