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EndoForce Post Approval Study

Recruitingn/aAges 18 Years - anyAllPhraxis, Inc.
NCT07146854 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

2 sites
MUSC Health Orangeburg
Orangeburg, United States
Spartanburg Regional Medical Center
Spartanburg, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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