Loading clinical trials...

Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial | Clinical Trials | Clareo Health

RECRUITINGNA

Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial

NCT06190717•Sonavex, Inc.

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

Age

18 - 84 years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

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.
+4 more criteria

Locations (20)

Trinity Research Group

Dothan, Alabama, United States

Southwest Kidney Institute

Phoenix, Arizona, United States

AKDHC Medical Research Services

Phoenix, Arizona, United States

AKDHC Center Tucson

Tucson, Arizona, United States

Orlando Health Heart and Vascular Institute

Orlando, Florida, United States

Northwestern University

Chicago, Illinois, United States

Kansas Nephrology Research Institute

Wichita, Kansas, United States

Boston Medical Center

Boston, Massachusetts, United States

MSU Health Care Heart and Vascular

Lansing, Michigan, United States

Capital Medical Center

Pennington, New Jersey, United States

Key Dates

Start Date

February 21, 2024

Primary Completion Date

February 1, 2026

Completion Date

February 1, 2026

Last Updated

December 1, 2025

Enrollment

304

ESTIMATED participants

Conditions

DiabetesEnd Stage Renal Disease

Interventions

EchoMark/EchoSure

DEVICE

Standard of Care

PROCEDURE

Contacts

Katy Feeny

CONTACT

443-862-2024 kfeeny@sonavex.com

Genetic Studies of Insulin and Diabetes

NCT00001987

Diabetes MellitusSevere Insulin Resistance

View study

RECRUITINGNA

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 1, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial

Inclusion Criteria

Exclusion Criteria

Genetic Studies of Insulin and Diabetes

Feasibility of a Tailored Online Self-compassion Intervention

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

Mesenchymal Stem Cell and Exosome Therapy for Diabetic Erectile Dysfunction

iGlarLixi CGM Study in Chinese T2D Individuals After OADs

Pharmacogenetics of the Response to GLP-1 in Mexican-Americans With Prediabetes