Actively Recruiting
EndoForce Post Approval Study for Vascular Access Grafts in End Stage Renal Disease
Led by Phraxis, Inc. · Updated on 2026-01-21
150
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are collecting long-term safety and performance data on the EndoForce System, a device used to connect a hemodialysis graft to a vein in patients with End Stage Renal Disease (ESRD). This observational study focuses on patients who require vascular access for hemodialysis. The device has been approved by the FDA and this study is not testing an experimental therapy or procedure. Participants will have an arteriovenous (AV) graft implanted using the EndoForce Connector for Endovascular Venous Anastomosis in the upper arm. Since this is an observational study, no new treatments are assigned, and the study monitors the real-world use of the approved device over time. During the 2-year follow-up, researchers will track outcomes such as the incidence of treatment-emergent adverse events, graft patency (how long the graft stays open), interventions needed to maintain graft function, and successful device use immediately after the procedure. Participants will follow their usual dialysis schedule and attend follow-up visits to assess safety and device performance throughout the study period.
CONDITIONS
Brief Title
EndoForce Post Approval Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 18 years of age or older.
- Patient requires the creation of a vascular access graft for hemodialysis due to End Stage Renal Disease.
- Patient can have the vascular access ePTFE graft placed in an upper arm.
- Patient or legal guardian understands the study and can comply with dialysis and follow-up requirements.
- Patient or legal guardian provides written informed consent.
You will not qualify if you...
- Any contraindications to the EndoForce Connector System according to its instructions for use.
- Patient is pregnant.
- Patient is enrolled in another dialysis or vascular investigational study without prior approval from the Sponsor.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants undergo implantation of the AV Graft using the EndoForce Connector for Endovascular Venous Anastomosis as part of routine care.
1 visit (procedure day)
Duration - 2 years
Participants are monitored for device success, adverse events, and graft patency over a 2-year period following implantation.
Regular follow-up visits over 2 years
Trial Site Locations
Total: 2 locations
1
MUSC Health Orangeburg
Orangeburg, South Carolina, United States, 29118
Not Yet Recruiting
2
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
Actively Recruiting
Research Team
J
John Zentgraf
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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