RecruitingNCT07146854

EndoForce Post Approval Study


Sponsor

Phraxis, Inc.

Enrollment

150 participants

Start Date

Jan 13, 2026

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is monitoring the long-term performance of a device called the EndoForce Connector System, which is used to create a vascular access graft for patients who need regular dialysis due to end-stage kidney disease. **You may be eligible if...** - You are 18 years old or older - You have end-stage kidney disease (kidneys no longer working adequately) and need to start dialysis - You need a new vascular access graft placed in your upper arm - You are able and willing to follow the dialysis schedule and attend follow-up visits **You may NOT be eligible if...** - You have a condition that makes the EndoForce device unsafe for you (per the device's instructions) - You are pregnant - You are already enrolled in another dialysis or vascular research study (without sponsor approval) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(2)

MUSC Health Orangeburg

Orangeburg, South Carolina, United States

Spartanburg Regional Medical Center

Spartanburg, South Carolina, United States

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NCT07146854


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