Actively Recruiting
EndoForce Post Approval Study
Led by Phraxis, Inc. · Updated on 2026-01-21
150
Participants Needed
2
Research Sites
202 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this observational study is to collect long-term safety and performance data for the use of the EndoForce System for connecting a hemodialysis graft to a vein in patients with End Stage Renal Disease. This is not an experimental procedure or an experimental therapy. This means that the study device has been approved by the FDA.
CONDITIONS
Official Title
EndoForce Post Approval Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 6518 years of age.
- Patient requires the creation of a vascular access graft for hemodialysis, secondary to a diagnosis of ESRD.
- Patient is able to have the vascular access ePTFE graft placed in an upper arm.
- Patient or his/her legal guardian understands the study and is willing and able to comply with the dialysis schedule and follow-up requirements.
- Patient or his/her legal guardian provides written informed consent.
You will not qualify if you...
- All contraindications for the EndoForce Connector System according to the IFU.
- 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
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
CONTACT
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here