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EndoForce Post Approval Study
RecruitingObservational study
Who can join
Ages 18 and older · All sexes
Full 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.
About the study
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.
Sponsor: Phraxis, Inc. · Participants: 150 · Started: Jan 13, 2026
Contact the study team
- John Zentgraf · Phone: 651-260-6673
Official record on ClinicalTrials.gov — NCT07146854
Locations in the U.S.
| South Carolina | MUSC Health Orangeburg, Orangeburg (Not yet recruiting) Spartanburg Regional Medical Center, Spartanburg |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.