EndoForce Post Approval Study

NCT07146854 | Recruiting DMC

• 1 other identifier: 009-034
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

End Stage Renal Disease (ESRD)

Keywords

Hemodialysis; Arteriovenous graft

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

Study Arms (1)

EndoForce

AV Graft implanted using the EndoForce Connector for Endovascular Venous Anastomosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with end stage renal disease requiring hemodialysis

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Phraxis, Inc.: lead

Study Sites (2)

MUSC Health Orangeburg

Orangeburg, South Carolina, 29118, United States

NOT YET RECRUITING

Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ari Kramer, MD

  Spartanburg Regional Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John Zentgraf

CONTACT

651-260-6673; jzentgraf@phraxis.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 28, 2025
• Study Start: January 13, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

US (2)