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

NCT04017910 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 17

Last updated 2022-10-12

Study results available
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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.

Conditions

  • Arteriovenous Fistula
  • Arteriovenous Graft

Interventions

DEVICE

EchoMark/EchoSure

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

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Sonavex, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-02
Primary Completion
2021-05-12
Completion
2021-05-12
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04017910 on ClinicalTrials.gov