EchoMark for Arteriovenous Fistula

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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

Multi-center trial to assess the feasibility and safety of the EchoMark LP and the EchoMark diagnostic ultrasound system for assessing AV fistula blood flow, diameter, and depth.

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.

Is EchoMark for Arteriovenous Fistula safe for humans?

The research articles do not provide specific safety data for EchoMark, but they discuss general safety concerns related to arteriovenous fistulas, such as risks of infection, bleeding, and thrombosis (blood clots). These complications are more common with certain types of vascular access, like catheters and AV grafts, compared to AV fistulas. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Early arteriovenous fistula failure associated with mortality and major adverse cardiovascular events in patients undergoing incident hemodialysis. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Quality Assurance and Preventing Serious Adverse Events in the Home Hemodialysis Setting. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Radiocephalic wrist arteriovenous fistula for hemodialysis: meta-analysis indicates a high primary failure rate. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

An arteriovenous fistula (AVF) functionality quality improvement tracking tool--developed and implemented to improve newly placed AVF utilization rates and patient outcomes. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Identifying vascular access complications among ESRD patients in Europe. A prospective, multicenter study. [2022]