EndoForce post-approval safety and performance follow-up for hemodialysis graft connections

EndoForce Post Approval Study

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
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Phraxis, Inc. (Industry-sponsored)
• Locations: 2 sites (Orangeburg, South Carolina and 1 other locations)
• Trial ID: NCT07146854 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

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.

Where this trial is running

Orangeburg, South Carolina and 1 other locations

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

Study contacts

• Principal investigator: Ari Kramer, MD — Spartanburg Regional Medical Center
• Study coordinator: John Zentgraf

Conditions End Stage Renal Disease; Hemodialysis; Arteriovenous graft