RecruitingDiabetesEnd Stage Renal Disease

Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial

Eligible age

18–84 yrs

Accepts

All genders

Locations

14 states

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

Check my eligibility →

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.

Sponsor: Sonavex, Inc.

You may qualify if…

✓ 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).

You may not qualify if…

✕ 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.