Kidney DiseasesNCT04896476

Prospective Feasibility Study Evaluating EchoMark LP Placement and EchoSure Measurements for Subjects Requiring Arteriovenous Fistulae

A study testing EchoMark / EchoSure in people with Kidney Diseases and Arteriovenous Fistula, run by Sonavex, Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Kidney Diseases, Arteriovenous Fistula
What is being tested?: EchoMark / EchoSure
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 4 sitesUnited States
Study dates: 21 Jan 2022to 30 Apr 2026
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males or non-pregnant, non-breastfeeding females ≥ 18 years of age but < 85 years of age at the time of informed consent
Subject is able and willing to provide written informed consent prior to receiving any non-standard of care, protocol specific procedures
Subject is willing and capable of complying with all required follow-up visits
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
Subject has an estimated life expectancy > 18 months
Subject is ambulatory (cane or walker are acceptable)

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Subjects presenting for upper arm autologous arteriovenous fistula creation
Vein diameter > 2.5 mm at the antecubital fossa via imaging
Artery diameter > 3 mm via imaging
Subject is not participating in another investigational clinical trial that has not met its primary endpoint. Participation in a post-market registry is acceptable.

Who cannot join

Subjects receiving a forearm fistula.
Subject has history of Steal Syndrome.
Subject who is immunocompromised or immunosuppressed.
Subject has had three previous failed AV fistulae for hemodialysis access
Subjects expecting to undergo major surgery within 60 days from the EchoMark implantation.
Known or suspected active infection on the day of the index procedure.

Show all 13Show fewer

Subjects who had infection(s) in the 30-day window prior to EchoMark placement to reduce the likelihood of partially treated infections that can seed the device and fistula
Subjects with diagnosed bleeding disorder, thrombocytopenia (platelet count <50,000), hypercoagulability, and history of recurrent deep vein thrombosis not related to AV access
Subjects with active malignancy
Subjects with a history of poor compliance with the dialysis protocol
Subjects with a known or suspected allergy to any of the device materials
Subjects with an existing fistula or graft
Subjects who are pregnant, plan to become pregnant, or are breastfeeding.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Surgical Specialist of Charlotte
Charlotte, North Carolina, 28207
Trinity Research Group
Dothan, Alabama, 36301
Michgan Vascular Center
Flint, Michigan, 48507
SKI Vascular Center
Peoria, Arizona, 85381

Other trials in United States

About this study

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.

Read the detailed description

This is a prospective, multi-center, single-arm, non-blinded clinical trial designed to evaluate the feasibility and safety of the EchoMark and the EchoSure in subjects undergoing new upper arm autologous arteriovenous fistula creation who require hemodialysis. All subjects will provide informed consent prior to undergoing any study procedures. The study will consists of multiple follow-up visits during the 52 week duration. Subjects are able to re-consent and remain in follow-up for an additional year.

Conditions: Kidney Diseases, Arteriovenous Fistula
Being tested: EchoMark / EchoSure
Medical subject headings: Kidney Diseases, Arteriovenous Fistula

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EchoMark / EchoSureDevice
The EchoMark is to be secured a minimum of 3 cm away from the anastomosis.
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.

Study groups in NCT04896476
Study group	Role	What they receive
EchoMark/EchoSure	Experimental	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. Receives: Device: EchoMark / EchoSure

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary Safety Endpoint
Composite of new major device related adverse events (MAEs) at 30 days post EchoMark implantation, as adjudicated by the Clinical Events Committee (CEC) including:
- Device or procedure-related death
- Device related infection
- Device related interventions
- Device related hospitalizations
- Fistula failure
- Fistula rupture
- Aneurysm
Measured: 30 Days
Primary Feasibility Endpoint
Rate of Technical Success defined as the successful implantation of the EchoMark implant. Technical success will be assessed from baseline to 4 months.
Measured: 4 Months
Rate of Technical Success Defined as the Successful Ability to Determine Blood Flow, Diameter, and Depth Measurements Using the EchoSure Diagnostic Ultrasound System. Technical Success Will be Assessed From Baseline to 4 Months.
Rate of Technical Success defined as the successful ability to determine blood flow, diameter, and depth measurements using the EchoSure diagnostic ultrasound system. Technical success will be assessed from baseline to 4 months.
Measured: 4 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jan 202230 Apr 2026

First posted21 May 2021
Study start21 Jan 2022
Primary completion24 Oct 2023
Study completion30 Apr 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Kidney DiseasesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04896476
Sponsor's protocol ID: IDE-F1-2021
Other IDs: R44HL147423
Status last verified: May 2026
First submitted: 10 May 2021
Last updated: 20 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Feasibility Study Evaluating EchoMark LP Placement and EchoSure Measurements for Subjects Requiring Arteriovenous Fistulae
ClinicalTrials.gov ID: NCT04896476
Acronym / sponsor ID: IDE-F1-2021
Conditions: Kidney Diseases, Arteriovenous Fistula
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Sonavex, Inc.Industry (pharma, biotech, devices)
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: 21 Jan 2022 (actual)
Primary completion: 24 Oct 2023 (actual)
Study completion: 30 Apr 2026 (actual)
First posted: 21 May 2021 (actual)
Results: Posted 18 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
EchoMark/EchoSure	Experimental	Device: EchoMark / EchoSureAll 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 may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Males or non-pregnant, non-breastfeeding females ≥ 18 years of age but < 85 years of age at the time of informed consent
Subject is able and willing to provide written informed consent prior to receiving any non-standard of care, protocol specific procedures
Subject is willing and capable of complying with all required follow-up visits
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
Subject has an estimated life expectancy > 18 months

Key exclusion criteria (13 listed)

Subjects receiving a forearm fistula.
Subject has history of Steal Syndrome.
Subject who is immunocompromised or immunosuppressed.
Subject has had three previous failed AV fistulae for hemodialysis access
Subjects expecting to undergo major surgery within 60 days from the EchoMark implantation.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EchoMark / EchoSureThe EchoMark is to be secured a minimum of 3 cm away from the anastomosis. 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.	Device	EchoMark/EchoSure

Primary outcome

Primary Safety Endpoint
Time frame: 30 Days
Composite of new major device related adverse events (MAEs) at 30 days post EchoMark implantation, as adjudicated by the Clinical Events Committee (CEC) including: * Device or procedure-related death * Device related infection * Device related interventions * Device related hospitalizations * Fistula failure * Fistula rupture * Aneurysm
Primary Feasibility Endpoint
Time frame: 4 Months
Rate of Technical Success defined as the successful implantation of the EchoMark implant. Technical success will be assessed from baseline to 4 months.
Rate of Technical Success Defined as the Successful Ability to Determine Blood Flow, Diameter, and Depth Measurements Using the EchoSure Diagnostic Ultrasound System. Technical Success Will be Assessed From Baseline to 4 Months.
Time frame: 4 Months
Rate of Technical Success defined as the successful ability to determine blood flow, diameter, and depth measurements using the EchoSure diagnostic ultrasound system. Technical success will be assessed from baseline to 4 months.

Results and safety

Results posted to the registry on 18 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
EchoMark	20	17

Primary outcome: Primary Safety Endpoint

Time frame: 30 Days. Number. Unit: MAES within 30 days post baseline visit

Measure	EchoMark n = 20
Value	0

Primary outcome: Primary Feasibility Endpoint

Time frame: 4 Months. Count of participants. Unit: Participants

Measure	EchoMark n = 20
Value	20

Primary outcome: Rate of Technical Success Defined as the Successful Ability to Determine Blood Flow, Diameter, and Depth Measurements Using the EchoSure Diagnostic Ultrasound System. Technical Success Will be Assessed From Baseline to 4 Months.

Time frame: 4 Months. Count of units. Unit: EchoSure Scans

Measure	EchoMark n = 20
Value	270

Adverse events

Time frame: The study duration was originally for 1 year. Adverse Events for all 20 subjects were reported for 1 year. Subjects were able to re-consent for an additional year of follow-up and adverse events were/ are being reported for an additional year for all subjects who re-consented.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
EchoMark	0 of 20 (0%)	16 of 20 (80%)	3 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing EchoMark / EchoSure in people with Kidney Diseases and Arteriovenous Fistula, run by Sonavex, Inc. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Safety Endpoint (time frame: 30 Days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04896476.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.