EndoForce Post Approval Study

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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Key information

Conditions

End Stage Renal Disease (ESRD) Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

MUSC Health Orangeburg, Orangeburg, South Carolina, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Incidence of Treatment-Emergent Adverse Events

Time frame: 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

Time frame: 2 years

The percentage of subjects free from loss of access of the study graft for hemodialysis.
AVG Primary Patency

Time frame: 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

Time frame: 2 years

The number of AVG interventions until access abandonment or through study completion.
Number of Participants with Acute Device Success

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

John Zentgraf

CONTACT

[email protected]

651-260-6673

Sponsors and collaborators

Lead sponsor

Phraxis, Inc.

Industry

Registry information

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2029
First posted: Aug 28, 2025
Registry last updated: Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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