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

October 10, 2022 updated by: Sonavex, Inc.
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

17

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients undergoing arteriovenous fistula creation for hemodialysis access

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance: Data Collection
Time Frame: 24 weeks
Data collection to verify accuracy
24 weeks
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.
24 Weeks
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.
24 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sonavex, Inc.

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 2, 2019

Primary Completion (ACTUAL)

May 12, 2021

Study Completion (ACTUAL)

May 12, 2021

Study Registration Dates

First Submitted

July 9, 2019

First Submitted That Met QC Criteria

July 10, 2019

First Posted (ACTUAL)

July 12, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 12, 2022

Last Update Submitted That Met QC Criteria

October 10, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-02
  • 2R44HL147423-04 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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