Status:
RECRUITING
Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial
Lead Sponsor:
Sonavex, Inc.
Conditions:
Diabetes
End Stage Renal Disease
Eligibility:
All Genders
18-84 years
Phase:
NA
Brief Summary
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 fo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT06190717
Start Date
February 21 2024
End Date
February 1 2026
Last Update
December 1 2025
Active Locations (20)
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1
Trinity Research Group
Dothan, Alabama, United States, 36301
2
Southwest Kidney Institute
Phoenix, Arizona, United States, 85004
3
AKDHC Medical Research Services
Phoenix, Arizona, United States, 85012
4
AKDHC Center Tucson
Tucson, Arizona, United States, 85754