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Official title Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial
ClinicalTrials.gov ID: NCT06190717
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 84
You may be able to join if
- 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...
- Subject has an estimated life expectancy \> 18 months.
You likely can't join if
- CKD Stage 1-4 or people 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.
- people expecting to undergo major surgery within 60 days from the EchoMark implantation.
- Known or suspected active infection on the day of the index procedure.
See the full eligibility 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 people presenting for upper arm autologous arteriovenous fistula creation that is not transposed for hemodialysis access.
- people 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.
- CKD Stage 1-4 or people 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.
- people expecting to undergo major surgery within 60 days from the EchoMark implantation.
- Known or suspected active infection on the day of the index procedure.
- people 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.
- people with diagnosed bleeding disorder, thrombocytopenia (platelet count \<50,000), hypercoagulability, and history of recurrent deep vein thrombosis not related to AV access.
- people with active malignancy.
- people with a history of poor compliance with the dialysis protocol.
- people with a known or suspected allergy to any of the device materials.
- people with an existing fistula or graft.
- people who are anticipated to convert to peritoneal dialysis or undergo a transplant within 6 months.
- people who are pregnant, planning on becoming pregnant, or are breast feeding.
The study team makes the final eligibility decision.
Where it's taking place
- Dothan, Alabama, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Orlando, Florida, United States
- Chicago, Illinois, United States
- Wichita, Kansas, United States
- Boston, Massachusetts, United States
- Lansing, Michigan, United States
- Pennington, New Jersey, United States
- New Hyde Park, New York, United States
- Concord, North Carolina, United States
- Greenville, South Carolina, United States
- Orangeburg, South Carolina, United States
- Chattanooga, Tennessee, United States
- Memphis, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Arlington, Virginia, United States
- Roanoke, Virginia, United States
- Virginia Beach, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 84 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dothan, Alabama, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Orlando, Florida, United States; Chicago, Illinois, United States; Wichita, Kansas, United States and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.