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

NCT ID: NCT04896476

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-21
• Study Completion Date: 2025-06-06

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EchoMark/EchoSure

All subjects will undergo a physician exam prior an arteriovenous fistula creation per the institution's standard of care. After the fistula creation is completed, but prior to closure, the EchoMark will be implanted under the outflow vein.

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.

Group Type: EXPERIMENTAL

EchoMark / EchoSure

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Males or non-pregnant, non-breastfeeding females ≥ 18 years of age but < 85 years of age at the time of informed consent

2. Subject is able and willing to provide written informed consent prior to receiving any non-standard of care, protocol specific procedures

3. Subject is willing and capable of complying with all required follow-up visits

4. Subject and/or Care Team agree that the distance and transportation resources from the subject's home to the clinic are reasonable for study participation and compliance

5. Subject has an estimated life expectancy > 18 months

6. Subject is ambulatory (cane or walker are acceptable)

7. Subjects presenting for upper arm autologous arteriovenous fistula creation

8. Vein diameter > 2.5 mm at the antecubital fossa via imaging

9. Artery diameter > 3 mm via imaging

10. Subject is not participating in another investigational clinical trial that has not met its primary endpoint. Participation in a post-market registry is acceptable.

Exclusion Criteria

1. Subjects receiving a forearm fistula.

2. Subject has history of Steal Syndrome.

3. Subject who is immunocompromised or immunosuppressed.

4. Subject has had three previous failed AV fistulae for hemodialysis access

5. Subjects expecting to undergo major surgery within 60 days from the EchoMark implantation.

6. Known or suspected active infection on the day of the index procedure.

7. Subjects who had infection(s) in the 30-day window prior to EchoMark placement to reduce the likelihood of partially treated infections that can seed the device and fistula

8. Subjects with diagnosed bleeding disorder, thrombocytopenia (platelet count <50,000), hypercoagulability, and history of recurrent deep vein thrombosis not related to AV access

9. Subjects with active malignancy

10. Subjects with a history of poor compliance with the dialysis protocol

11. Subjects with a known or suspected allergy to any of the device materials

12. Subjects with an existing fistula or graft

13. Subjects who are pregnant, plan to become pregnant, or are breastfeeding.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Sonavex, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Trinity Research Group

Dothan, Alabama, United States

SKI Vascular Center

Peoria, Arizona, United States

Michgan Vascular Center

Flint, Michigan, United States

Surgical Specialist of Charlotte

Charlotte, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R44HL147423

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IDE-F1-2021

Identifier Type: -

Identifier Source: org_study_id