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

Terminated

• Conditions: Arteriovenous Graft; Arteriovenous Fistula

• Registration Number: NCT04017910
• Lead Sponsor: Sonavex, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2019-07-09
• Study First Submitted QC: 2019-07-10
• Study First Posted: 2019-07-12
• Study Start: 2019-12-02
• Primary Completion: 2021-05-12
• Study Completion: 2021-05-12
• Results First Submitted: 2021-06-14
• Results First Submitted QC: 2021-09-20
• Results First Posted: 2021-10-18
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-10
• Last Update Posted: 2022-10-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Age > 18 years
• Patients presenting for upper extremity arteriovenous fistula construction with autologous tissue for the purpose of eventual hemodialysis access where the surgeon has selected EchoMark and EchoSure as the optimal method of vascular monitoring based on clinical assessment and plan
• Patient is able to sign informed consent and able to participate in all testing associated with this clinical investigation
• Women of childbearing potential have a negative pregnancy test

Exclusion Criteria

• Age <18 years old
• Patient unable to sign informed consent
• Patient participating in another investigational device or pharmacological study
• Prisoner or patient from vulnerable populations as defined in 45 CFR 46.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Performance: Data Collection	24 weeks	Data collection to verify accuracy
Safety Endpoint	24 Weeks	Number of Subjects with Freedom from Serious Adverse Events (SAEs) during the EchoMark implantation procedure and sub-sequent post-operative period.
Performance Endpoint	24 Weeks	Data collection to understand the natural history of flow physiology in AV fistulas and classify the fistula that will fail.

Trial Locations

Locations (2)

University of Maryland School of Medicine; 🇺🇸 Baltimore, Maryland, United States

Roanoke Vascular Access Center; 🇺🇸 Roanoke, Virginia, United States