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

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ClinicalTrials.gov Identifier: NCT04017910
Recruitment Status : Suspended (to address inquiry.)
First Posted : July 12, 2019
Last Update Posted : January 12, 2021
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Sonavex, Inc.

Brief Summary:
This study evaluates the role of an implanted ultrasonic fiducial marker and automated Duplex for evaluating the maturation of peripheral arteriovenous fistulae created for the purpose of establishing long term hemodialysis access in patients with end stage renal disease.

Condition or disease Intervention/treatment
Arteriovenous Fistula Arteriovenous Graft Hemodialysis Complication Device: Implantation of ultrasonic fiduciary

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Automated 3D Ultrasound-based Surveillance of Arteriovenous Fistula Maturation for Post-operative Hemodialysis Patients
Actual Study Start Date : December 2, 2019
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Fistulas


Intervention Details:
  • Device: Implantation of ultrasonic fiduciary
    Implantation of a small ultrasonic apparent device at the time of arteriovenous fistula creation.


Primary Outcome Measures :
  1. Arteriovenous fistula maturation rate [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. The volume of blood per unit time through the fistula anastomosis as measured by ultrasound [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients undergoing arteriovenous fistula creation for hemodialysis access
Criteria

Inclusion Criteria:

  • Able to consent to participation
  • Need for arteriovenous fistula creation for long term hemodialysis creation

Exclusion Criteria:

  • Unable to consent
  • Does not want to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04017910


Locations
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United States, Maryland
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21202
United States, Virginia
Roanoke Vascular Access Center
Roanoke, Virginia, United States, 24014
Sponsors and Collaborators
Sonavex, Inc.
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Rishi Kundhi, MD University of Maryland, College Park
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Responsible Party: Sonavex, Inc.
ClinicalTrials.gov Identifier: NCT04017910    
Other Study ID Numbers: 2019-02
2R44HL147423-04 ( U.S. NIH Grant/Contract )
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Arteriovenous Fistula
Fistula
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities