Status:
NOT_YET_RECRUITING
EndoForce Post Approval Study
Lead Sponsor:
Phraxis, Inc.
Conditions:
End Stage Renal Disease (ESRD)
Eligibility:
All Genders
18+ years
Brief Summary
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 Re...
Eligibility Criteria
Inclusion
- Patient is ≥18 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2029
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT07146854
Start Date
November 1 2025
End Date
November 1 2029
Last Update
September 4 2025
Active Locations (2)
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1
MUSC Health Orangeburg
Orangeburg, South Carolina, United States, 29118
2
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303