Maturation of AV Fistula with Automated Sonography Assessments
Maturation of Arteriovenous Fistula with Automated Sonography Assessments (MAFASA) Trial
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Clinical Trial Information
Trial Contact: Marquart, Vashnie; Soto, William; Rodriguez, Jessica M; Ngo, George M.
Trial Phone: 321-843-1037 ; 321-843-1179 ; 3218413270 ; 3218439657
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IRB No: W23.088.05.
Protocol Abbrev: MAFASA
Principal Investigator: Gino Santos Castaneda, MD
Phase: Device: Risk not yet determined
Age Group: Adult
Secondary Protocol No: MAFASA-2021
Treatment: Diagnostic Arm: All DIAG subjects will undergo standard AVF creation and have the EchoMark LP implanted at the time of AVF creation. Subjects will be assessed every 2 weeks (± 1 week) (but no more frequently than weekly) with the EchoSure system and a physical exam until fistula maturation occurs and/or permanent access use is achieved. During the 6-week visit, subjects will also receive a study specific limited duplex to compare the results with the EchoSure. The investigators will be blinded to this duplex exam only.
Therapies Involved: Procedural
ClinicalTrials.gov ID: NCT04017910
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Objective
To demonstrate the safety of the EchoMark/EchoSure System and evaluate the impact of the information provided by the system to support management of AVFs during maturation. Time to Clinical Maturation will be compared to the Standard of Care.
Time to Clinical Maturation is defined as the number of days from baseline procedure to date of Clinical Maturation. Clinical Maturation is defined as 75% of dialysis sessions with successful 2 needle cannulation. Date of Clinical Maturation is defined as first date of the 4-week window when Clinical Maturation is achieved. -
Key Eligibility
Subject is currently on dialysis or is expected to start dialysis in the next 6 weeks. Vein diameter ≥ 2.5 mm at the antecubital fossa per vein mapping. Artery diameter ≥ 2.5 mm per vein mapping
