Using automated ultrasound to assess arteriovenous fistula maturation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of the EchoMark®/EchoSure® System for monitoring the maturation of arteriovenous fistulas (AVFs) in patients with end-stage renal disease. It is a prospective, multi-center, randomized trial that compares biweekly ultrasound assessments against standard care to determine if this approach can reduce the time to clinical maturation of AVFs. Participants will be monitored closely to assess the performance of the ultrasound system in facilitating timely dialysis access.

Why it matters

Who can join: the full rules

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.

Where it's running

• Trinity Research Group
  Dothan, Alabama, United States Recruiting
• Southwest Kidney Institute
  Phoenix, Arizona, United States Recruiting
• AKDHC Medical Research Services
  Phoenix, Arizona, United States Recruiting
• AKDHC Center Tucson
  Tucson, Arizona, United States Recruiting
• Orlando Health Heart and Vascular Institute
  Orlando, Florida, United States Recruiting
• Sarasota Medical Health Care System
  Sarasota, Florida, United States Recruiting

Study contacts

• Study coordinator: Katy Feeny
• Email: kfeeny@sonavex.com
• Phone: 443-862-2024

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.