NCT06190717 · Sonavex, Inc.
Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial
(MAFASA)
What this study is about
This is a forward-looking, multi-center, two-treatment group$1, randomly assigned 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.
View original scientific description
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.
Interventions
DEVICE
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.
PROCEDURE
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.
Primary outcome measures
Primary Safety Endpoint
Time frame: 6 months
Freedom from the following through 6 months as adjudicated by the CEC: 1. Clinically significant misplacement or migration of the EchoMark implant. 2. Vessel or tissue injury caused by the EchoMark implant procedure of the implant over time, requiring surgical intervention. 3. Infection of tissues surrounding the EchoMark implant requiring IV/ 4. Complication requiring explantation of the EchoMark implant.
Primary Effectiveness Endpoint
Time frame: 6 months
Time to clinical maturation
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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.
Where
- Dothan, Alabama
- Phoenix, Arizona
- Tucson, Arizona
- Orlando, Florida
- Chicago, Illinois
- Wichita, Kansas
- Boston, Massachusetts
- Lansing, Michigan
- Pennington, New Jersey
- New Hyde Park, New York
- Concord, North Carolina
- Greenville, South Carolina
And 8 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations