Status:
TERMINATED
Automated 3D Ultrasound-based Surveillance of Arteriovenous Fistula Maturation for Post-operative Hemodialysis Patients
Lead Sponsor:
Sonavex, Inc.
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Arteriovenous Fistula
Arteriovenous Graft
Eligibility:
All Genders
18+ years
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.
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 uppe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 2 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 12 2021
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04017910
Start Date
December 2 2019
End Date
May 12 2021
Last Update
October 12 2022
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21202
2
Roanoke Vascular Access Center
Roanoke, Virginia, United States, 24014