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

NCT04017910 | Terminated Results FDA Device

• 2 other identifiers: 2019-022R44HL147423-04
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 2

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.

Conditions

Arteriovenous Fistula; Arteriovenous Graft

Outcome Measures

Primary Outcomes (3)

• Performance: Data Collection

  Data collection to verify accuracy

  24 weeks

• Performance Endpoint

  Data collection to understand the natural history of flow physiology in AV fistulas and classify the fistula that will fail.

  24 Weeks

• 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

Interventions

EchoMark/EchoSure DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing arteriovenous fistula creation for hemodialysis access

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sonavex, Inc.: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

University of Maryland School of Medicine

Baltimore, Maryland, 21202, United States

Location

Roanoke Vascular Access Center

Roanoke, Virginia, 24014, United States

Location

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This was designed as 2 Stage Study. Subjects were only enrolled into Stage 1 and the study has been terminated One immunocompromised transplant subject experienced a potential local wound infection and the event was deemed to be possibly device related. Two subjects passed away during the study. One was deemed not to be in relation to the study device. The second was deemed possibly related due to a sudden death within the thirty-day postoperative window.

Results Point of Contact

• Title: Katy Feeny
• Organization: Sonavex

kfeeny@sonavex.com

443-862-2024

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 12, 2019
• Study Start: December 2, 2019
• Primary Completion: May 12, 2021
• Study Completion: May 12, 2021
• Last Updated: October 12, 2022
• Results First Posted: October 18, 2021

Record last verified: 2022-10

Locations

US (2)