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ACTIVE NOT RECRUITING
NCT04896476
NA

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

Sponsor: Sonavex, Inc.

View on ClinicalTrials.gov

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

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.

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