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Diagnostic Device

EchoMark for Arteriovenous Fistula

N/A
Waitlist Available
Research Sponsored by Sonavex, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects presenting for upper arm autologous arteriovenous fistula creation
Males or non-pregnant, non-breastfeeding females ≥ 18 years of age but < 85 years of age at the time of informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial assesses whether a new ultrasound system is safe and effective for measuring blood flow, diameter, and depth in AV fistulas.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include complications related to device implantation such as infection risk at the site of placement or allergic reactions to device materials.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am getting a fistula in my arm using my own blood vessels.
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I am a man or a woman not pregnant or breastfeeding, aged 18 to 84.
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I am willing and able to attend all required follow-up visits.
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I can walk by myself or with a cane or walker.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Feasibility Endpoint
Primary Safety Endpoint
Other outcome measures
12-month patency rate
6-month patency rate
Clinical maturation success rate
+18 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: EchoMarkExperimental Treatment1 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.

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,834 Previous Clinical Trials
47,310,615 Total Patients Enrolled
1 Trials studying Arteriovenous Fistula
17 Patients Enrolled for Arteriovenous Fistula
Sonavex, Inc.Lead Sponsor
3 Previous Clinical Trials
721 Total Patients Enrolled
2 Trials studying Arteriovenous Fistula
321 Patients Enrolled for Arteriovenous Fistula

Media Library

EchoMark (Diagnostic Device) Clinical Trial Eligibility Overview. Trial Name: NCT04896476 — N/A
Arteriovenous Fistula Research Study Groups: EchoMark
Arteriovenous Fistula Clinical Trial 2023: EchoMark Highlights & Side Effects. Trial Name: NCT04896476 — N/A
EchoMark (Diagnostic Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04896476 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is geriatric inclusion being considered in this experiment?

"This clinical trial is seeking participants above the age of majority and beneath 85 years old."

Answered by AI

Are there multiple health care institutions conducting this experiment across the state?

"Currently, this clinical trial has 4 sites for patient recruitment. These cities are Charlotte, Dothan and Flint as well as one additional location. For convenience, it is best to select the closest option in order to reduce any associated travel burden."

Answered by AI

Is there an ongoing recruitment of participants for this clinical experiment?

"Affirmative, clinicaltrials.gov details confirm that this research experiment is actively searching for volunteers. The original listing was posted on the 21st of January 2022 and last modified on October 10th 2022; currently, 20 individuals are required at 4 separate medical facilities."

Answered by AI

Who is the ideal candidate for participation in this research endeavor?

"To qualify for this innovative research, applicants must possess arteriovenous fistula and be aged between 18 to 85. Presently, the team is looking for 20 individuals who fit these criteria."

Answered by AI

How many participants are engaging in this clinical experiment?

"Yes, the data on clinicaltrials.gov verifies that this experiment is still accepting applicants. It was initially posted in late January of 2022 and updated as recently as October 10th of the same year. A total of 20 participants are needed to be sourced from 4 distinct medical locations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Prospective Feasibility Study Evaluating EchoMark LP Placement and EchoSure Measurements for Subjects Requiring Arteriovenous Fistulae
2022. "Prospective Feasibility Study Evaluating EchoMark LP Placement and EchoSure Measurements for Subjects Requiring Arteriovenous Fistulae". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04896476.
~6 spots leftby Apr 2025
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