Automated 3D Ultrasound-based Surveillance of Arteriovenous Fistula Maturation for Post-operative Hemodialysis Patients
NCT ID: NCT04017910
Last Updated: 2022-10-12
Study Results
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View full resultsBasic Information
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TERMINATED
17 participants
OBSERVATIONAL
2019-12-02
2021-05-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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EchoMark/EchoSure
Each subject will have an EchoMark implanted at the time of arteriovenous fistula creation, and undergo EchoSure and duplex imaging follow-up.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Sonavex, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Maryland School of Medicine
Baltimore, Maryland, United States
Roanoke Vascular Access Center
Roanoke, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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2019-02
Identifier Type: -
Identifier Source: org_study_id
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