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.

Study Overview

• Status: Recruiting
• Conditions: End Stage Renal Disease (ESRD)

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: John Zentgraf; Phone Number: 651-260-6673; Email: jzentgraf@phraxis.com

Study Locations

• United States
  • South Carolina
    • Orangeburg, South Carolina, United States, 29118
      • Not yet recruiting
      • MUSC Health Orangeburg
      • Contact: Virginia Anderson; Phone Number: 803-395-3878; Email: andersvi@musc.edu
      • Principal Investigator: Mark London, MD
    • Spartanburg, South Carolina, United States, 29303
      • Recruiting
      • Spartanburg Regional Medical Center
      • Principal Investigator: Ari Kramer, MD
      • Contact: Darla Howard; Phone Number: 864-590-5521; Email: DHoward@srhs.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with end stage renal disease requiring hemodialysis

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
EndoForce; AV Graft implanted using the EndoForce Connector for Endovascular Venous Anastomosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AVG Cumulative Patency	The percentage of subjects free from loss of access of the study graft for hemodialysis.	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.	2 years
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.	2 years
Number of AVG Interventions to Maintain Patency	The number of AVG interventions until access abandonment or through study completion.	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.	Through end of procedure

Collaborators and Investigators

• Sponsor: Phraxis, Inc.
• Investigators: Principal Investigator: Ari Kramer, MD, Spartanburg Regional Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: August 21, 2025
• First Submitted That Met QC Criteria: August 21, 2025
• First Posted (Actual): August 28, 2025

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Hemodialysis; Arteriovenous graft
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Pathological Conditions, Signs and Symptoms; Kidney Failure, Chronic
• Other Study ID Numbers: 009-034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD that underlie results in a publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No