| NCT ID | NCT07146854 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Phraxis, Inc. |
| Condition | End Stage Renal Disease (ESRD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-01-13 |
| Primary Completion | 2029-12 |
Trial Parameters
Eligibility Fast-Check
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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 Renal Disease. This is not an experimental procedure or an experimental therapy. This means that the study device has been approved by the FDA.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.