EchoMark/EchoSure for Arteriovenous Fistula

(MAFASA Trial)

Recruiting at 11 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

Trial Summary

What is the purpose of this trial?

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.

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+