EndoForce Post Approval Study

Phraxis, Inc.150 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

End Stage Renal Disease (ESRD)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

NOT_YET_RECRUITING

Spartanburg Regional Medical Center

Spartanburg, South Carolina, United States

RECRUITING

Outcomes

Primary Outcomes

Incidence of Treatment-Emergent Adverse Events

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.

Time frame: 2 years

AVG Cumulative Patency

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

Time frame: 2 years

AVG Primary Patency

The percentage of subjects free from the first occurrence of either access thrombosis or an access procedure performed to maintain access patency.

Time frame: 2 years

Number of AVG Interventions to Maintain Patency

The number of AVG interventions until access abandonment or through study completion.

Time frame: 2 years

Number of Participants with Acute Device Success

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.

Time frame: Through end of procedure

Central Contacts

John Zentgraf

CONTACT

651-260-6673 jzentgraf@phraxis.com

Data from ClinicalTrials.gov

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