DiabetesMAFASANCT06190717
Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial
A study testing EchoMark/EchoSure in people with Diabetes and End Stage Renal Disease, run by Sonavex, Inc. at 23 sites in United States.
Trial 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 for assessing fistula maturation and reducing time to Clinical Maturation. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Diabetes, End Stage Renal Disease
- What is being tested?
- EchoMark/EchoSure
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 23 sitesUnited States
- Study dates
- 21 Feb 2024to 1 Feb 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
23 sites in 1 country. Contact the study team or a site near you to ask about taking part.
23 sites in 1 country
United States23 sites, 21 recruiting
- Recruiting
HealthQare Associates
Arlington, Virginia, 22201
M Lewandowski, 703-908-0800, Magdalena.Lewandowski@AzuraCare.com
Homayoun Hashemi, MD, FACS, RVT, RPVI
- Recruiting
Boston Medical Center
Boston, Massachusetts, 02118
C Roddy
J Siracuse, MD
- Recruiting
Galen Medical Group
Chattanooga, Tennessee, 37421
K Norwood
S Phade, MD
- Recruiting
Northwestern University
Chicago, Illinois, 60611
J Kasperek
V Rohan, MD
- Recruiting
Vascular Care of South Carolina
Columbia, South Carolina, 29203
A. Phillips, 803-252-3373, Alicia.Phillips-Pough@Azuracare.com
Dion Franga, MD
- Recruiting
Atrium Health
Concord, North Carolina, 28025
G Brown
Christopher Mitromaras, MD
- Recruiting
Baylor Scott & White Heart and Vascular Hospital
Dallas, Texas, 75226
R Shabbir
Stephen Hohmann, MD
- Recruiting
Trinity Research Group
Dothan, Alabama, 36301
E Ivey
Jason Beaver, MD
- Recruiting
Prisma Health
Greenville, South Carolina, 29605
M Salle
Sagar Gandhi, MD
- Recruiting
Aqua Research Institute Llc
Houston, Texas, 77058
R Rachal
Rupal Patel, MD
- Completed
MSU Health Care Heart and Vascular
Lansing, Michigan, 48910
- Terminated
Fresenius Vascular Care Memphis MSO
Memphis, Tennessee, 38115
- Recruiting
Northwell Health
New Hyde Park, New York, 11042
Virginia Wairimu
Yana Etkin, MD
- Recruiting
Medical University of South Carolina Health Orangeburg
Orangeburg, South Carolina, 29118
V Anderson
Mark London, MD
- Recruiting
Orlando Health Heart and Vascular Institute
Orlando, Florida, 32806
G. Nyo
G Castaneda, MD
- Recruiting
Capital Medical Center
Pennington, New Jersey, 08534
L Gant
Christine Lotto, MD
- Recruiting
Southwest Kidney Institute
Phoenix, Arizona, 85004
J Rodriguez
Umar Waheed, MD
- Recruiting
AKDHC Medical Research Services
Phoenix, Arizona, 85012
A Zabala
S Wang, MD
- Recruiting
Physicians Care of Virginia
Roanoke, Virginia, 24014
A Johnson
Ryan Evans, MD
- Not yet recruiting
Sarasota Medical Health Care System
Sarasota, Florida, 34239
Regulatory Affairs, 941-917-2225, ResearchInstitute@smh.com
Jason Wagner, MD
- Recruiting
AKDHC Center Tucson
Tucson, Arizona, 85754
A Munoz, 520-622-3569, amgallego@akdhc.com
Z Yang, MD
- Recruiting
Sentara Health
Virginia Beach, Virginia, 23454
S Havert
Samuel Steerman, MD
- Recruiting
Kansas Nephrology Research Institute
Wichita, Kansas, 67214
A Anderson, 316-262-2045, aanderson@researchmgmt.com
Dennis Ross, MD
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.
- Conditions
- Diabetes, End Stage Renal Disease
- Being tested
- EchoMark/EchoSure, Standard of Care
- Medical subject headings
- Diabetes Mellitus, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchoMark/EchoSureDevice
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 CareProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Arm | Experimental | 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. Receives: Device: EchoMark/EchoSure |
| Standard of Care | Active comparator | 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. Receives: Procedure: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
Freedom from the following through 6 months as adjudicated by the CEC:
- Clinically significant misplacement or migration of the EchoMark implant.
- Vessel or tissue injury caused by the EchoMark implant procedure of the implant over time, requiring surgical intervention.
- Infection of tissues surrounding the EchoMark implant requiring IV/
- Complication requiring explantation of the EchoMark implant.
Measured: 6 months
Primary Effectiveness Endpoint
Time to clinical maturation
Measured: 6 months
Secondary outcomes (9)
Difference between EchoSure and Duplex Flow Measurements
Difference between log10-transformed EchoSure and Duplex flow measurements of blood flow for assessment of measurement agreement in the diagnostic arm.
Measured: 6 Months
EchoSure Depth Comparison
Difference between EchoSure and CoreLab measurements of depth for assessment of measurement agreement in the diagnostic arm.
Measured: 6 Months
EchoSure Diameter Comparison
Difference between EchoSure and CoreLab measurement of diameter for assessment of measurement agreement in the diagnostic arm.
Measured: 6 Months
EchoMark/EchoSure System Technical Success
Technical Success defined as the successful implantation of the EchoMark implant and the ability to complete each scan to determine the blood flow, diameter, and depth measurements at the EchoMark using the EchoSure diagnostic ultrasound system from baseline to Clinical Maturation, fistula failure, or 4 months, whichever is sooner.
Measured: 4 Months
CVC Removal
Time to CVC removal by subject group
Measured: 6 Months
Rate of Hospitalization
Rate of hospitalization(s) by subject group from baseline to Clinical Maturation.
Measured: 6 Months
AV Fistula Maturation Rate
Percent of AVFs created that mature by 180 days by subject group.
Measured: 6 Months
Total Cost of Care
Total cost of care, defined by National average Medicare payment rate (facility and professional fees) for procedures and care provided to subject by subject group from baseline to Clinical Maturation.
Measured: 6 Months
Freedom from Events through 30 and 90 Days
Freedom from the following through 30 and 90 days from the baseline procedure as adjudicated by the CEC:
- Clinically significant misplacement or migration of the EchoMark implant.
- Vessel or tissue injury caused by the EchoMark implant procedure of the implant over time, requiring surgical intervention.
- Infection of tissues surrounding the EchoMark implant requiring IV antibiotic treatment.
- Complication requiring explantation of the EchoMark implant.
Measured: 30 Days and 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start21 Feb 2024
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sonavex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190717
- Sponsor's protocol ID
- MAFASA-2023
- Acronym
- MAFASA
- Status last verified
- Oct 2026
- First submitted
- 19 Dec 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No