EchoMark for Arteriovenous Fistula

Not currently recruiting at 3 trial locations

Overseen By Katy Feeny

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sonavex, Inc.

Disqualifiers: Steal syndrome, Immunocompromised, Bleeding disorder, Active malignancy, others

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

Compensation: Varies

Number of Visits: 1

Duration: Baseline procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called EchoMark, which helps doctors assess the function of an arteriovenous fistula (a connection between an artery and a vein for dialysis). EchoMark uses an ultrasound system to measure blood flow and the size and depth of the fistula. This study targets individuals planning to have a fistula created in their upper arm and who have experienced no more than two previous failed fistula attempts. Participants should be able to walk with or without a cane or walker and have sufficient resources to travel to clinic visits. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance dialysis care.

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 and EchoSure system is safe for assessing AV fistula?

Research has shown that EchoMark has been tested for safety and effectiveness. In an earlier study, EchoMark was used with another device called EchoSure, and they worked well together. This study examined whether these devices could aid the proper development of an AV fistula, a connection between an artery and a vein used for dialysis.

The study reported that patients tolerated EchoMark well. Additionally, during a six-month follow-up, no major safety issues were identified. This suggests that EchoMark is safe for use, with no serious side effects linked to it. While more information might be needed for complete confidence, early results are promising for its safety in medical settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for arteriovenous fistulas, which typically involves regular physical exams and ultrasound evaluations, EchoMark introduces a novel approach by utilizing an implantable device under the outflow vein. This device, combined with the EchoSure system, allows for non-invasive, real-time monitoring of blood flow and vessel dimensions without needing a sonographer present. Researchers are excited because it streamlines the process, potentially giving doctors more immediate and accurate data, which could lead to better patient outcomes and fewer complications.

What evidence suggests that the EchoMark system is effective for assessing AV fistula?

Research has shown that the EchoMark and EchoSure system effectively checks blood flow and the size of blood vessels in arteriovenous fistulas, which are crucial for patients requiring dialysis. In this trial, all participants will receive the EchoMark implant. Studies have found that this implant can help these fistulas develop more quickly. Clinical trial data suggest that the EchoMark implant can be placed successfully and provide accurate readings, with successful placement being a key indicator of its effectiveness. This technology aims to simplify the monitoring of fistulas for doctors, eliminating the need for complicated equipment. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

Adults aged 18-85 needing an arteriovenous fistula for kidney disease, able to consent and follow-up. Must live reasonably close to the clinic, be ambulatory, have a life expectancy over 18 months, and not in conflicting trials. Excludes those with Steal Syndrome, immune issues, multiple failed fistulas or major upcoming surgery.

Inclusion Criteria

Subject has an estimated life expectancy > 18 months

I am getting a fistula in my arm using my own blood vessels.

Subject and/or Care Team agree that the distance and transportation resources from the subject's home to the clinic are reasonable for study participation and compliance

Exclusion Criteria

I plan to have major surgery within 2 months after getting an EchoMark implant.

I currently have an active cancer.

I haven't had infections in the last 30 days before my EchoMark placement.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo arteriovenous fistula creation and EchoMark LP implantation

Baseline procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness of the EchoMark and EchoSure systems

52 weeks

Multiple visits (in-person)

Extension

Participants may re-consent to remain in follow-up for an additional year

12 months

What Are the Treatments Tested in This Trial?

Interventions

• EchoMark

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 hemodialysis in patients with kidney disease across multiple centers.

How Is the Trial Designed?

Group I: EchoMark/EchoSure Experimental Treatment 1 Intervention

All subjects will undergo a physician exam prior an arteriovenous fistula creation per the institution's standard of care. After the fistula creation is completed, but prior to closure, the EchoMark will be implanted under the outflow vein. The follow-up EchoSure scans will be conducted by the designated EchoSure user without the investigator and without the sonographer/RVT conducting the Duplex exam in the room, either during the routine work-up prior to the surgeon seeing the patient or after. The EchoSure results for flow, and vessel depth and diameter are shown as numerical values on the screen of the EchoSure device.

Who Is Running the Clinical Trial?

Sonavex, Inc.

Lead Sponsor

Trials

4

Recruited

360+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

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

Prospective Feasibility Study Evaluating EchoMark LP ... Data collected from this study will provide preliminary device safety and effectiveness data for the use of the EchoMark/EchoSure System in.

2. 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.

3. sonavex.com sonavex.com/2024/01/02/sonavex-announces-successful-clinical-study-of-echomark-echosure-and-initiation-of-the-mafasa-randomized-controlled-trial/

Sonavex Announces Successful Clinical Study of ... This trial is designed to provide Level 1 data to demonstrate how the use of EchoMark & EchoSure will reduce time to AV fistula maturation and ...

4. 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 ...

5. withpower.com withpower.com/trial/phase-fistula-2024-ca8d8

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

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10523460/

Results of a benchtop study - PMC Arteriovenous fistulae (AVF) are considered the preferred hemodialysis access but up to 50% of all AVF created in the United States never mature.

7. 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 ... This is a prospective, multi-center, single-arm, non-blinded clinical trial designed to evaluate the feasibility and safety of the EchoMark ...