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EndoForce Post Approval Study | Clinical Trials | Clareo Health

RECRUITING

EndoForce Post Approval Study

NCT07146854•Phraxis, Inc.

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

Age

18 - No limit years

Sex

ALL

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.

Locations (2)

MUSC Health Orangeburg

Orangeburg, South Carolina, United States

Spartanburg Regional Medical Center

Spartanburg, South Carolina, United States

Key Dates

Start Date

January 13, 2026

Primary Completion Date

December 1, 2029

Completion Date

December 1, 2029

Last Updated

January 21, 2026

Enrollment

150

ESTIMATED participants

Conditions

End Stage Renal Disease (ESRD)

Contacts

John Zentgraf

CONTACT

651-260-6673 jzentgraf@phraxis.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 21, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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EndoForce Post Approval Study

Inclusion Criteria

Exclusion Criteria

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