Prospective Feasibility Study Evaluating EchoMark LP Placement and EchoSure Measurements for Subjects Requiring Arteriovenous Fistulae

NAActive, not recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

January 21, 2022

Primary Completion Date

October 24, 2023

Study Completion Date

June 6, 2025

Conditions
Kidney DiseasesArteriovenous Fistula
Interventions
DEVICE

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."

Trial Locations (4)

28207

Surgical Specialist of Charlotte, Charlotte

36301

Trinity Research Group, Dothan

48507

Michgan Vascular Center, Flint

85381

SKI Vascular Center, Peoria

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

Sonavex, Inc.

INDUSTRY