EndoForce post-approval safety and performance follow-up for hemodialysis graft connections
Official title: EndoForce Post Approval Study
Run by Phraxis, Inc. · NCT07146854 · Data updated 2026-11-12
This follow-up will see how well the FDA-approved EndoForce device connects hemodialysis grafts to veins and how safe it is for adults with end-stage renal disease.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Phraxis, Inc. Industry-sponsored |
| Locations | 2 sites (Orangeburg, South Carolina and 1 other locations) |
| Status | Recruiting |
| Started | January 13, 2026 |
| Main results expected | December 2029 |
| Study ends | December 2029 |
| Registry record updated | January 21, 2026 |
| Trial ID | NCT07146854 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with end-stage renal disease who need an upper-arm ePTFE hemodialysis graft, can provide informed consent, and can attend follow-up visits are ideal candidates.
✕Probably not a fit
Patients who are pregnant, have contraindications listed in the device IFU, or are enrolled in another investigational dialysis or vascular study without sponsor approval are not eligible and unlikely to benefit from this follow-up.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational, post-approval follow-up will collect long-term safety and performance data on the FDA-approved EndoForce Connector System when used to attach upper-arm ePTFE hemodialysis grafts to veins. Adults with end-stage renal disease who require a vascular graft and can provide informed consent will be enrolled and treated per the device instructions for use. No experimental therapies are given; clinicians will report device performance, complications, and graft patency during scheduled dialysis and follow-up visits. Data will be collected at participating South Carolina sites and submitted to the sponsor for real-world safety surveillance.
Why it matters
Potential benefit: If successful, the data could improve understanding of long-term safety and help clinicians optimize graft-connection techniques to reduce complications.
How similar studies have gone: The device has FDA approval based on prior clinical data, and this post-approval registry is collecting additional real-world long-term safety and performance information.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States Recruiting -
MUSC Health Orangeburg
Orangeburg, South Carolina, United States Not yet recruiting
Study contacts
- Principal investigator: Ari Kramer, MD — Spartanburg Regional Medical Center
- Study coordinator: John Zentgraf
- Email: jzentgraf@phraxis.com
- Phone: 651-260-6673
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.