Status:
ACTIVE_NOT_RECRUITING
Prospective Feasibility Study Evaluating EchoMark LP Placement and EchoSure Measurements for Subjects Requiring Arteriovenous Fistulae
Lead Sponsor:
Sonavex, Inc.
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Kidney Diseases
Arteriovenous Fistula
Eligibility:
All Genders
18-85 years
Phase:
NA
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 autolo...
Eligibility Criteria
Inclusion
- Males or non-pregnant, non-breastfeeding females ≥ 18 years of age but \< 85 years of age at the time of informed consent
- Subject is able and willing to provide written informed consent prior to receiving any non-standard of care, protocol specific procedures
- Subject is willing and capable of complying with all required follow-up visits
- 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
- Subject has an estimated life expectancy \> 18 months
- Subject is ambulatory (cane or walker are acceptable)
- Subjects presenting for upper arm autologous arteriovenous fistula creation
- Vein diameter \> 2.5 mm at the antecubital fossa via imaging
- Artery diameter \> 3 mm via imaging
- 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
- Subjects receiving a forearm fistula.
- Subject has history of Steal Syndrome.
- Subject who is immunocompromised or immunosuppressed.
- Subject has had three previous failed AV fistulae for hemodialysis access
- Subjects expecting to undergo major surgery within 60 days from the EchoMark implantation.
- Known or suspected active infection on the day of the index procedure.
- 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
- Subjects with diagnosed bleeding disorder, thrombocytopenia (platelet count \<50,000), hypercoagulability, and history of recurrent deep vein thrombosis not related to AV access
- Subjects with active malignancy
- Subjects with a history of poor compliance with the dialysis protocol
- Subjects with a known or suspected allergy to any of the device materials
- Subjects with an existing fistula or graft
- Subjects who are pregnant, plan to become pregnant, or are breastfeeding.
Key Trial Info
Start Date :
January 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 6 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04896476
Start Date
January 21 2022
End Date
June 6 2025
Last Update
February 18 2025
Active Locations (4)
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1
Trinity Research Group
Dothan, Alabama, United States, 36301
2
SKI Vascular Center
Peoria, Arizona, United States, 85381
3
Michgan Vascular Center
Flint, Michigan, United States, 48507
4
Surgical Specialist of Charlotte
Charlotte, North Carolina, United States, 28207