EndoForce Post Approval Study

Recruiting now

Conditions studied: End Stage Renal Disease (ESRD)

In brief

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.

Key facts

Study ID

NCT07146854

Run by

Phraxis, Inc.

People needed

150

Starts

2026-01-13

Expected to finish

2029-12-01

Last updated by the study team

2026-01-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Spartanburg Regional Medical Center — Spartanburg, South Carolina, United States (enrolling)
• MUSC Health Orangeburg — Orangeburg, South Carolina, United States

Full record on ClinicalTrials.gov

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