Actively Recruiting
Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial
Led by Sonavex, Inc. · Updated on 2026-04-13
304
Participants Needed
21
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or non-pregnant, non-breastfeeding females aged 18 to less than 85 years
- Able and willing to provide written informed consent
- Willing and able to comply with all follow-up visits
- Reasonable distance and transportation resources to the clinic
- Estimated life expectancy greater than 18 months
- Ambulatory (cane or walker allowed)
- Stage 5 chronic kidney disease (eGFR less than 10) or end stage renal disease
- Scheduled for upper arm autologous arteriovenous fistula creation (not transposed) for hemodialysis access
- Currently on dialysis via central venous catheter or imminently requiring dialysis (GFR less than 10)
- Vein diameter at least 2.5 mm at the antecubital fossa
- Artery diameter at least 2.5 mm
- Not participating in another investigational clinical trial that has not met its primary endpoint (post-market registry allowed)
You will not qualify if you...
- Chronic kidney disease stages 1 to 4 or not needing upper arm autologous arteriovenous fistula creation for hemodialysis access
- History of Steal Syndrome
- Immunocompromised or immunosuppressed
- History of three previous failed arteriovenous fistulae for hemodialysis
- Expecting major surgery within 60 days of EchoMark implantation
- Known or suspected active infection on the day of the procedure
- Infection within 30 days before EchoMark placement
- Diagnosed bleeding disorder, thrombocytopenia (platelets less than 50,000), hypercoagulability, or recurrent deep vein thrombosis unrelated to AV access
- Active malignancy
- History of poor compliance with dialysis protocol
- Known or suspected allergy to device materials
- Existing fistula or graft
- Anticipated conversion to peritoneal dialysis or transplant within 6 months
- Pregnant, planning pregnancy, or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
Trinity Research Group
Dothan, Alabama, United States, 36301
Actively Recruiting
2
Southwest Kidney Institute
Phoenix, Arizona, United States, 85004
Actively Recruiting
3
AKDHC Medical Research Services
Phoenix, Arizona, United States, 85012
Actively Recruiting
4
AKDHC Center Tucson
Tucson, Arizona, United States, 85754
Actively Recruiting
5
Orlando Health Heart and Vascular Institute
Orlando, Florida, United States, 32806
Actively Recruiting
6
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
7
Kansas Nephrology Research Institute
Wichita, Kansas, United States, 67214
Actively Recruiting
8
Boston Medical Center
Boston, Massachusetts, United States, 02118
Actively Recruiting
9
MSU Health Care Heart and Vascular
Lansing, Michigan, United States, 48910
Actively Recruiting
10
Capital Medical Center
Pennington, New Jersey, United States, 08534
Actively Recruiting
11
Northwell Health
New Hyde Park, New York, United States, 11042
Actively Recruiting
12
Atrium Health
Concord, North Carolina, United States, 28025
Actively Recruiting
13
Prisma Health
Greenville, South Carolina, United States, 29605
Actively Recruiting
14
Medical University of South Carolina Health Orangeburg
Orangeburg, South Carolina, United States, 29118
Actively Recruiting
15
Galen Medical Group
Chattanooga, Tennessee, United States, 37421
Actively Recruiting
16
Fresenius Vascular Care Memphis MSO
Memphis, Tennessee, United States, 38115
Terminated
17
Baylor Scott & White Heart and Vascular Hospital
Dallas, Texas, United States, 75226
Actively Recruiting
18
Aqua Research Institute Llc
Houston, Texas, United States, 77058
Actively Recruiting
19
HealthQare Associates
Arlington, Virginia, United States, 22201
Actively Recruiting
20
Physicians Care of Virginia
Roanoke, Virginia, United States, 24014
Actively Recruiting
21
Sentara Health
Virginia Beach, Virginia, United States, 23454
Actively Recruiting
Research Team
K
Katy Feeny
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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