NCT04896476

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Sonavex, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, multi-center, single-arm, non-blinded clinical trial designed to evaluate the feasibility and safety of the EchoMark and the EchoSure in subjects undergoing new upper arm autologous arteriovenous fistula creation who require hemodialysis. All subjects will provide informed consent prior to undergoing any study procedures. The study will consists of multiple follow-up visits during the 52 week duration. Subjects are able to re-consent and remain in follow-up for an additional year.

Conditions

• Kidney Diseases
• Arteriovenous Fistula

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-01-21
• Primary completion: 2023-10-24
• Completion: 2025-06-06
• First posted: 2021-05-21
• Last updated: 2025-02-18
• Results posted: 2025-02-18

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study