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

Arteriovenous Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04017910
• Other study ID #: 2019-02
• Secondary ID: 2R44HL147423-04
• Status: Terminated
• Start date: December 2, 2019
• Est. completion date: May 12, 2021

Study information

• Verified date: October 2022
• Source: Sonavex, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: May 12, 2021
• Est. primary completion date: May 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Arteriovenous Graft
• Fistula

Intervention

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.

Locations

Country	Name	City	State
United States	University of Maryland School of Medicine	Baltimore	Maryland
United States	Roanoke Vascular Access Center	Roanoke	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Sonavex, Inc.	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

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