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Prospective Feasibility Study Evaluating EchoMark LP Placement and EchoSure Measurements for Subjects Requiring Arteriovenous Fistulae
Sponsor: Sonavex, Inc.
Summary
Multi-center trial to assess the feasibility and safety of the EchoMark LP and the EchoMark diagnostic ultrasound system for assessing AV fistula blood flow, diameter, and depth.
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2022-01-21
Completion Date
2025-06-06
Last Updated
2025-02-18
Healthy Volunteers
No
Conditions
Interventions
EchoMark / EchoSure
The EchoMark is to be secured a minimum of 3 cm away from the anastomosis. The follow-up EchoSure scans will be conducted by the designated EchoSure user without the investigator and without the sonographer/RVT conducting the Duplex exam in the room, either during the routine work-up prior to the surgeon seeing the patient or after. The EchoSure results for flow, and vessel depth and diameter are shown as numerical values on the screen of the EchoSure device.
Locations (4)
Trinity Research Group
Dothan, Alabama, United States
SKI Vascular Center
Peoria, Arizona, United States
Michgan Vascular Center
Flint, Michigan, United States
Surgical Specialist of Charlotte
Charlotte, North Carolina, United States