EndoForce Post Approval Study

NCT07146854 · tracked via the Priya Life Science USA tracker

Sponsor

Phraxis, Inc

Phase

Observational

Started

2026-01-13

Last updated

2026-01-21

Condition(s) studied

End Stage Renal Disease (ESRD)

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Incidence of Treatment-Emergent Adverse Events — 2 years
All device and/or procedure-related events and all major adverse events that reasonably suggest the involvement of the EndoForce and that require or result in any of the following: death, emergent surgery, events requiring hospitalization, events requiring percutaneous interventions, vascular access infection requiring treatment, significant bleeding, pseudoaneurysm and serious adverse events. EndoForce migration, inadequate seal and leakage will also be collected acutely and at each in-person follow-up visit.
AVG Cumulative Patency — 2 years
The percentage of subjects free from loss of access of the study graft for hemodialysis.
AVG Primary Patency — 2 years
The percentage of subjects free from the first occurrence of either access thrombosis or an access procedure performed to maintain access patency.
Number of AVG Interventions to Maintain Patency — 2 years
The number of AVG interventions until access abandonment or through study completion.
Number of Participants with Acute Device Success — Through end of procedure
AV graft flow at the end of the procedure as determined by palpable graft thrill and/or audible bruit, without significant bleeding or emergent surgery.

Trial sites (2)

Facility	City	Region	Status
MUSC Health Orangeburg	Orangeburg	South Carolina	Not Yet Recruiting
Spartanburg Regional Medical Center	Spartanburg	South Carolina	Recruiting

Other trials for the same condition

Pivotal Study of the Velocity™ pAVF System Recruiting

To Compare the Efficacy and Safety of the ATEV With AVF in Female Patients With End-Stage Renal Disease Requiring Hemodialysis Active, not recruiting

Early Feasibility Study of the Velocity™ Percutaneous Arterio-Venous Fistula System for Creating Hemodialysis Vascular Access Active, not recruiting

A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07146854 on ClinicalTrials.gov ↗ ← All trials in the USA