Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-84
SponsorSonavex, Inc.
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- EchoMark/EchoSure
- Standard of Care
Treatment groups
304 Participants
are divided into 2 treatment groupsLocations
21Alabama
Trinity Research Group36301, Dothan United States
Arizona
AKDHC Medical Research Services85012, Phoenix United States
Southwest Kidney Institute85004, Phoenix United States
AKDHC Center Tucson85754, Tucson United States
Sponsors and collaborators
Sonavex, Inc.
Lead sponsor
Source ClinicalTrials.gov