EchoMark/EchoSure for Arteriovenous Fistula

(MAFASA Trial)

Recruiting at 16 trial locations

Overseen By Katy Feeny

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sonavex, Inc.

Disqualifiers: Steal syndrome, Immunocompromised, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 6 months

304 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new ultrasound system, EchoMark/EchoSure, to assist individuals with kidney failure who require an arteriovenous fistula for dialysis. The goal is to determine if using this system every two weeks can accelerate fistula maturation and readiness for use. The trial includes two groups: one will use the EchoMark/EchoSure system, while the other will adhere to standard care practices. Individuals with severe kidney disease needing a new fistula for dialysis may be suitable candidates for this study. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance dialysis access for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the EchoMark/EchoSure System is safe for AVF diagnostic ultrasound?

Research has shown that the EchoMark/EchoSure system is generally well-tolerated. In earlier studies, researchers tested the EchoMark, a dissolvable implant used to mark a connection between an artery and a vein, for safety and practicality. These studies did not find any major safety problems directly linked to the system. It is important to note that the EchoMark/EchoSure system is designed to help doctors monitor the development of this connection, but specific safety details for this use are not fully covered in the available research.

This trial is labeled as "Not Applicable" for phase, indicating it might not have undergone the usual stages of drug testing that provide detailed safety information. However, since the system is intended to assist with diagnosis rather than directly treat a condition, the focus is on its effectiveness rather than potential side effects. Participants should always consult the trial team for the most personalized information. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about EchoMark and EchoSure because they offer a new way to monitor arteriovenous fistula maturation. Unlike traditional methods that rely on physical exams and periodic ultrasound assessments, EchoMark is a tiny device that is implanted and works with the EchoSure system to provide real-time, continuous monitoring of the fistula. This innovative approach could lead to more timely interventions and improved outcomes for patients, as it allows for more frequent and accurate assessments without the need for frequent hospital visits. By potentially streamlining the process of fistula maturation, this technology may enhance patient care and reduce the burden on healthcare systems.

What evidence suggests that the EchoMark/EchoSure System is effective for assessing fistula maturation?

This trial will compare the EchoMark/EchoSure System with standard care for arteriovenous fistulas. Research has shown that the EchoMark/EchoSure System effectively aids the proper development of arteriovenous fistulas, which connect an artery and a vein. Studies have demonstrated the system's success in accurately marking and monitoring these fistulas. By detecting problems early, the system can prevent issues as the fistula matures. The EchoMark implant, designed to dissolve safely over time, serves as a marker for ultrasound exams. By monitoring blood flow and fistula growth, the EchoSure system aims to prepare the fistula for use sooner. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 with severe kidney issues who need dialysis, can walk (even with a cane or walker), and have veins big enough for an arteriovenous fistula. They should expect to live more than 18 months, be able to follow the study plan, and travel to the clinic.

Inclusion Criteria

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

Subject has an estimated life expectancy > 18 months

Exclusion Criteria

Subjects who are pregnant, planning on becoming pregnant, or are breast feeding

Subjects with an existing fistula or graft

Subjects with a history of poor compliance with the dialysis protocol

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the EchoMark implant and are assessed biweekly with the EchoSure system until fistula maturation or permanent access use is achieved

Up to 6 months

Biweekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with evaluations per KDOQI guidelines

6 months

Monthly visits (in-person)

Extension

Participants may continue to be monitored for long-term outcomes and adverse events

Up to 12 months

What Are the Treatments Tested in This Trial?

Interventions

• EchoMark/EchoSure

Trial Overview The trial tests EchoMark/EchoSure System's ability to check how well a new blood vessel connection matures in patients needing dialysis. It compares regular care with biweekly ultrasound checks using this system.

How Is the Trial Designed?

Group I: Diagnostic Arm Experimental Treatment 1 Intervention

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.

Group II: Standard of Care Active Control 1 Intervention

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.

EchoMark/EchoSure is already approved in United States for the following indications:

Approved in United States as EchoMark/EchoSure System for:

• Assessment of arteriovenous fistula maturation for dialysis patients

Who Is Running the Clinical Trial?

Sonavex, Inc.

Lead Sponsor

Trials

4

Recruited

360+

Citations

1. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/76/NCT04896476/Prot_SAP_000.pdf

Prospective Feasibility Study Evaluating EchoMark LP ... EchoMark LP is a bioresorbable implant used as ultrasound marker for marking an arteriovenous fistula. The EchoSure System for AVF is a ...

2. journals.sagepub.com journals.sagepub.com/doi/10.1177/11297298241287609

Bedside 3D ultrasound fistula maturation assessment by ... The primary effectiveness (feasibility) endpoint was technical success, defined as the successful implantation of the EchoMark implant and the ...

3. reporter.nih.gov reporter.nih.gov/project-details/10480217

RePORT RePORTER - National Institutes of Health (NIH) | OVERALL IMPACT: ESV2 will allow rapid and early detection of problems with arteriovenous fistulas before malfunction in the maturation stage. This will both ...

4. withpower.com withpower.com/trial/phase-fistula-8-2021-e634a

EchoMark for Arteriovenous Fistula · Info for Participants Trial Overview The trial is testing EchoMark LP's safety and effectiveness alongside the EchoSure system to monitor blood flow in AV fistulas used for ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06190717

NCT06190717 | Maturation of Arteriovenous Fistula With ... This is a prospective, multi-center, two-arm, randomized trial to quantify the performance of the EchoMark®/EchoSure® System for AVF diagnostic ultrasound ...

6. ctv.veeva.com ctv.veeva.com/study/prospective-feasibility-study-evaluating-echomark-lp-placement-and-echosure-measurements-for-subject

Prospective Feasibility Study Evaluating EchoMark LP ... Multi-center trial to assess the feasibility and safety of the EchoMark LP and the EchoMark diagnostic ultrasound system for assessing AV ...

7. clinicaltrials.gov clinicaltrials.gov/ct2/show/record/NCT04896476

Prospective Feasibility Study Evaluating EchoMark LP ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.