EndoForce Post Approval Study

Pharxis

Status: Enrolling

Conditions: End Stage Renal Disease (ESRD)

Study type: Observational

Funder types: Industry

Identifiers

NCT07146854

009-034

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

150 participants in 1 patient group

EndoForce

Description:

AV Graft implanted using the EndoForce Connector for Endovascular Venous Anastomosis