Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial
NCT ID: NCT06190717
Last Updated: 2025-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
304 participants
INTERVENTIONAL
2024-02-21
2026-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Diagnostic Arm
All subjects will have the EchoMark implanted. Subjects will be assessed every 2 weeks (+/- 1 week) (but no more frequently than weekly) with the EchoSure system until fistula maturation occurs and/or permanent access use is achieved.
EchoMark/EchoSure
Subjects assigned to the Diagnostic Arm will have the EchoMark implanted at the time of AVF creation. The subject will return every 2 weeks for a follow-up assessment to include an EchoSure scan until fistula maturation and/or permanent access use is achieved. The EchoSure scans are to be reviewed by the investigator(s) or delegated study staff and aid in the determination when a further assessment, including a physical exam, is required to determine cannulation clearance or if an intervention(s) may be required to prevent failure of fistula maturation. All physical exams will include assessing the fistula for bruit and thrill. The subject's medical history will be reviewed at each visit and will include all interventions, cannulation attempts, and adverse event reporting.
Standard of Care
Subjects will be evaluated per KDOQI guidelines (with physical examination at approximately 2 weeks (+/- 1 week) and between 4 and 6 weeks (+/- 1 week)). If evaluation yields abnormal findings, subjects will receive a Duplex ultrasound assessment (DUS). All SOC Arm subjects will be followed per the institution's standard of care until fistula maturation occurs and/or permanent access use is achieved but no more frequently than once per month.
Standard of Care
Subjects are assessed using standard of care per KDOQI guidelines, which includes a physical exam at the 2-week follow-up visit and at the 4-6-week follow-up visit. All follow-up visits will include an assessment of adverse events and medical history review to include all interventions, cannulation attempts, and laboratory results. If evaluation yields an abnormal finding, subjects will undergo a Duplex ultrasound assessment and treatment under the institution's standard of care. All SOC Arm subjects will be followed per the institution's standard of care until fistula maturation occurs and/or permanent access use is achieved but no more frequently than once per month.
Interventions
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EchoMark/EchoSure
Subjects assigned to the Diagnostic Arm will have the EchoMark implanted at the time of AVF creation. The subject will return every 2 weeks for a follow-up assessment to include an EchoSure scan until fistula maturation and/or permanent access use is achieved. The EchoSure scans are to be reviewed by the investigator(s) or delegated study staff and aid in the determination when a further assessment, including a physical exam, is required to determine cannulation clearance or if an intervention(s) may be required to prevent failure of fistula maturation. All physical exams will include assessing the fistula for bruit and thrill. The subject's medical history will be reviewed at each visit and will include all interventions, cannulation attempts, and adverse event reporting.
Standard of Care
Subjects are assessed using standard of care per KDOQI guidelines, which includes a physical exam at the 2-week follow-up visit and at the 4-6-week follow-up visit. All follow-up visits will include an assessment of adverse events and medical history review to include all interventions, cannulation attempts, and laboratory results. If evaluation yields an abnormal finding, subjects will undergo a Duplex ultrasound assessment and treatment under the institution's standard of care. All SOC Arm subjects will be followed per the institution's standard of care until fistula maturation occurs and/or permanent access use is achieved but no more frequently than once per month.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
84 Years
ALL
No
Sponsors
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Sonavex, Inc.
INDUSTRY
Responsible Party
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Locations
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Trinity Research Group
Dothan, Alabama, United States
Southwest Kidney Institute
Phoenix, Arizona, United States
AKDHC Medical Research Services
Phoenix, Arizona, United States
AKDHC Center Tucson
Tucson, Arizona, United States
Orlando Health Heart and Vascular Institute
Orlando, Florida, United States
Northwestern University
Chicago, Illinois, United States
Kansas Nephrology Research Institute
Wichita, Kansas, United States
Boston Medical Center
Boston, Massachusetts, United States
MSU Health Care Heart and Vascular
Lansing, Michigan, United States
Capital Medical Center
Pennington, New Jersey, United States
Northwell Health
New Hyde Park, New York, United States
Atrium Health
Concord, North Carolina, United States
Prisma Health
Greenville, South Carolina, United States
Medical University of South Carolina Health Orangeburg
Orangeburg, South Carolina, United States
Galen Medical Group
Chattanooga, Tennessee, United States
Fresenius Vascular Care Memphis MSO
Memphis, Tennessee, United States
Baylor Scott & White Heart and Vascular Hospital
Dallas, Texas, United States
Aqua Research Institute Llc
Houston, Texas, United States
Physicians Care of Virginia
Roanoke, Virginia, United States
Sentara Health
Virginia Beach, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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E Ivey
Role: primary
J Rodriguez
Role: primary
A Zabala
Role: primary
G. Nyo
Role: primary
J Kasperek
Role: primary
C Roddy
Role: primary
A Burghardt
Role: primary
L Gant
Role: primary
Virginia Wairimu
Role: primary
G Brown
Role: primary
M Salle
Role: primary
V Anderson
Role: primary
K Norwood
Role: primary
R Shabbir
Role: primary
R Rachal
Role: primary
A Johnson
Role: primary
S Havert
Role: primary
Other Identifiers
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MAFASA-2023
Identifier Type: -
Identifier Source: org_study_id
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