Arteriovenous FistulaNCT04017910

Automated 3D Ultrasound-based Surveillance of Arteriovenous Fistula Maturation for Post-operative Hemodialysis Patients

An observational study of Arteriovenous Fistula and Arteriovenous Graft, run by Sonavex, Inc. at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is a two stage, prospective, multi-center study to evaluate the EchoMark and EchoSure devices in patients undergoing peripheral arteriovenous fistula creation for hemodialysis access. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Arteriovenous Fistula, Arteriovenous Graft
What is being tested?: EchoMark/EchoSure
Type of treatment: Medical device
How many people: 17 participants
Where: 2 sitesUnited States
Study dates: 2 Dec 2019to 12 May 2021
Phase: Observational
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Adult patients undergoing arteriovenous fistula creation for hemodialysis access

Who may be able to join

Age > 18 years
Patients presenting for upper extremity arteriovenous fistula construction with autologous tissue for the purpose of eventual hemodialysis access where the surgeon has selected EchoMark and EchoSure as the optimal method of vascular monitoring based on clinical assessment and plan
Patient is able to sign informed consent and able to participate in all testing associated with this clinical investigation
Women of childbearing potential have a negative pregnancy test

Who cannot join

Age <18 years old
Patient unable to sign informed consent
Patient participating in another investigational device or pharmacological study
Prisoner or patient from vulnerable populations as defined in 45 CFR 46.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Maryland School of Medicine
Baltimore, Maryland, 21202
Roanoke Vascular Access Center
Roanoke, Virginia, 24014

Other trials in United States

About this study

This is a two stage, prospective, multi-center study to evaluate the EchoMark and EchoSure devices in patients undergoing peripheral arteriovenous fistula creation for hemodialysis access.

Read the detailed description

This is Stage 1 of a 2 stage protocol, targeting to enroll 60 patients in prospective, single arm, non-randomized, multi-center observational study to record objective data in patients undergoing upper extremity arteriovenous fistula construction with autologous tissue for the purpose of eventual hemodialysis access, in whom the EchoMark is placed at the site of vascular anastomosis. Follow-up visits include EchoSure and duplex imaging.

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

What participants receive

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

EchoMark/EchoSureDevice
Each subject will have an EchoMark implanted at the time of arteriovenous fistula creation, and undergo EchoSure and duplex imaging follow-up.

What is being measured

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

Performance: Data Collection
Data collection to verify accuracy
Measured: 24 weeks
Performance Endpoint
Data collection to understand the natural history of flow physiology in AV fistulas and classify the fistula that will fail.
Measured: 24 Weeks
Safety Endpoint
Number of Subjects with Freedom from Serious Adverse Events (SAEs) during the EchoMark implantation procedure and sub-sequent post-operative period.
Measured: 24 Weeks

Timeline

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

2 Dec 201912 May 2021

First posted12 Jul 2019
Study start2 Dec 2019
Primary completion12 May 2021
Study completion12 May 2021

Why it stopped: Conversion to IDE

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 Arteriovenous FistulaStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04017910
Sponsor's protocol ID: 2019-02
Other IDs: 2R44HL147423-04
Status last verified: Oct 2022
First submitted: 9 Jul 2019
Last updated: 12 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

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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A First-In-Man Study to Assess Safety and Efficacy of Ultra High Pressure PTA Balloon ULTRAVIOLET in Treating A-V Fistula Stenosis
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Active, not recruitingObservational study
Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion (WRAP)
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All Arteriovenous Fistula trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Automated 3D Ultrasound-based Surveillance of Arteriovenous Fistula Maturation for Post-operative Hemodialysis Patients
ClinicalTrials.gov ID: NCT04017910
Acronym / sponsor ID: 2019-02
Conditions: Arteriovenous Fistula, Arteriovenous Graft
Study type: Observational
Recruitment status: TerminatedReason stopped: Conversion to IDE
Enrolment: 17 participants (actual)
Lead sponsor: Sonavex, Inc.Industry (pharma, biotech, devices)
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: 2 Dec 2019 (actual)
Primary completion: 12 May 2021 (actual)
Study completion: 12 May 2021 (actual)
First posted: 12 Jul 2019 (actual)
Results: Posted 18 Oct 2021

Clinical summary

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

This is a two stage, prospective, multi-center study to evaluate the EchoMark and EchoSure devices in patients undergoing peripheral arteriovenous fistula creation for hemodialysis access.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adult patients undergoing arteriovenous fistula creation for hemodialysis access

Key inclusion criteria (4 listed)

Age > 18 years
Patients presenting for upper extremity arteriovenous fistula construction with autologous tissue for the purpose of eventual hemodialysis access where the surgeon has selected EchoMark and EchoSure as the optimal method of vascular monitoring based on clinical assessment and plan
Patient is able to sign informed consent and able to participate in all testing associated with this clinical investigation
Women of childbearing potential have a negative pregnancy test

Key exclusion criteria (4 listed)

Age <18 years old
Patient unable to sign informed consent
Patient participating in another investigational device or pharmacological study
Prisoner or patient from vulnerable populations as defined in 45 CFR 46.

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/EchoSureEach subject will have an EchoMark implanted at the time of arteriovenous fistula creation, and undergo EchoSure and duplex imaging follow-up.	Device	–

Primary outcome

Performance: Data Collection
Time frame: 24 weeks
Data collection to verify accuracy
Performance Endpoint
Time frame: 24 Weeks
Data collection to understand the natural history of flow physiology in AV fistulas and classify the fistula that will fail.
Safety Endpoint
Time frame: 24 Weeks
Number of Subjects with Freedom from Serious Adverse Events (SAEs) during the EchoMark implantation procedure and sub-sequent post-operative period.

Results and safety

Results posted to the registry on 18 Oct 2021, 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/EchoSure Stage 1	17	17

Primary outcome: Performance: Data Collection

Time frame: 24 weeks

Population analysed: Data was not collected.

Primary outcome: Performance Endpoint

Time frame: 24 Weeks

Population analysed: Data was not collected.

Primary outcome: Safety Endpoint

Time frame: 24 Weeks. Count of participants. Unit: Participants

Measure	EchoMark/EchoSure Stage 1 n = 17
Value	16

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
EchoMark/EchoSure Stage 1	1 of 17 (5.9%)	5 of 17 (29.4%)	2 of 17

Limitations and caveats (from the sponsor): This was designed as 2 Stage Study. Subjects were only enrolled into Stage 1 and the study has been terminated One immunocompromised transplant subject experienced a potential local wound infection and the event was deemed to be possibly device related. Two subjects passed away during the study. One was deemed not to be in relation to the study device. The second was deemed possibly related due to a sudden death within the thirty-day postoperative window.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Arteriovenous Fistula

Recruiting
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
End Stage Renal Disease
Enrolling by invitationObservational study
Okami Medical ALPHA Registry
Arterial Bleed, Pulmonary Arteriovenous Malformation
Recruiting
Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial
Diabetes, End Stage Renal Disease
Not yet recruiting
A First-In-Man Study to Assess Safety and Efficacy of Ultra High Pressure PTA Balloon ULTRAVIOLET in Treating A-V Fistula Stenosis
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Active, not recruitingObservational study
Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion (WRAP)
Venous Stenosis, Venous Occlusion

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.

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

Questions about this trial

What is this clinical trial studying?

An observational study of Arteriovenous Fistula and Arteriovenous Graft, run by Sonavex, Inc. at 2 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 Oct 2021). 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?

Performance: Data Collection (time frame: 24 weeks). 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 NCT04017910.

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 12 Oct 2022.