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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04017910
Recruitment Status : Terminated (Conversion to IDE)
First Posted : July 12, 2019
Results First Posted : October 18, 2021
Last Update Posted : October 18, 2021
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Sonavex, Inc.

Brief 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.

Condition or disease Intervention/treatment
Arteriovenous Fistula Arteriovenous Graft Device: EchoMark/EchoSure

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.

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Study Type : Observational
Actual Enrollment : 17 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
Actual Primary Completion Date : May 12, 2021
Actual Study Completion Date : May 12, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Fistulas


Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Performance: Data Collection [ Time Frame: 24 weeks ]
    Data collection to verify accuracy

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • 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.

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)
  Study Documents (Full-Text)

Documents provided by Sonavex, Inc.:
Informed Consent Form  [PDF] May 14, 2019

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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
Results First Posted: October 18, 2021
Last Update Posted: October 18, 2021
Last Verified: September 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