RecruitingNot Applicable

EndoForce Post Approval Study

United States150 participantsStarted 2026-01-13

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Incidence of Treatment-Emergent Adverse Events

Timeframe: 2 years

AVG Cumulative Patency

Timeframe: 2 years

AVG Primary Patency

Timeframe: 2 years

Number of AVG Interventions to Maintain Patency

Timeframe: 2 years

Number of Participants with Acute Device Success

Timeframe: Through end of procedure

Trial details

NCT IDNCT07146854

SponsorPhraxis, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2029-12

Contact for this trial

John Zentgraf

651-260-6673 jzentgraf@phraxis.com

View on ClinicalTrials.gov More End Stage Renal Disease (ESRD) trials