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Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial

Sponsored by Sonavex, Inc.

About this study

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.

Where this study is enrolling (7)

  • AKDHC Medical Research Services

    Phoenix, Arizona

    Call 602-997-0484

    This research site can be reached directly by phone. Call to ask about this study.

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  • AKDHC Center Tucson

    Tucson, Arizona

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  • Southwest Kidney Institute

    Phoenix, Arizona

    Call 480-610-6100

    This research site can be reached directly by phone. Call to ask about this study.

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  • Northwestern University

    Chicago, Illinois

    I'm interested

  • Kansas Nephrology Research Institute

    Wichita, Kansas

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Show all 7 locations
Who can participate

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.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.