NCT04017910

Automated 3D Ultrasound-based Surveillance of Arteriovenous Fistula Maturation for Post-operative Hemodialysis Patients

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 17 (actual)
• Sponsor: Sonavex, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a two stage, prospective, multi-center study to evaluate the EchoMark and EchoSure devices in patients undergoing peripheral arteriovenous fistula creation for hemodialysis access.

Detailed description

This is Stage 1 of a 2 stage protocol, targeting to enroll 60 patients in prospective, single arm, non-randomized, multi-center observational study to record objective data in patients undergoing upper extremity arteriovenous fistula construction with autologous tissue for the purpose of eventual hemodialysis access, in whom the EchoMark is placed at the site of vascular anastomosis. Follow-up visits include EchoSure and duplex imaging.

Conditions

• Arteriovenous Fistula
• Arteriovenous Graft

Interventions

Type	Name	Description
DEVICE	EchoMark/EchoSure	Each subject will have an EchoMark implanted at the time of arteriovenous fistula creation, and undergo EchoSure and duplex imaging follow-up.

Timeline

• Start date: 2019-12-02
• Primary completion: 2021-05-12
• Completion: 2021-05-12
• First posted: 2019-07-12
• Last updated: 2022-10-12
• Results posted: 2021-10-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study