MedTrace Logo

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

NCT04896476 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-20

Study results available
· View outcomes & findings →

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.

Conditions

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.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Sonavex, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-21
Primary Completion
2023-10-24
Completion
2026-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04896476 on ClinicalTrials.gov