Recruiting

Observational Study

Sponsor:

Phraxis, Inc.

Code:

NCT07146854

Conditions

End Stage Renal Disease (ESRD)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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)

Study ID

NCT07146854

Start date

Jan 13, 2026

Status verified date

Jan, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

EndoForce

AV Graft implanted using the EndoForce Connector for Endovascular Venous Anastomosis

Primary outcome measure

  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: 2 years ]
  • AVG Cumulative Patency [ Time Frame: 2 years ]
  • AVG Primary Patency [ Time Frame: 2 years ]
  • Number of AVG Interventions to Maintain Patency [ Time Frame: 2 years ]
  • Number of Participants with Acute Device Success [ Time Frame: Through end of procedure ]

Central Contacts and Locations

Central contacts

John Zentgraf

651-260-6673jzentgraf@phraxis.com

Locations

Spartanburg Regional Medical Center

Recruiting

Spartanburg, South Carolina, United States, 29303

Contacts

Darla Howard

864-590-5521DHoward@srhs.com

Principal Investigator:

Ari Kramer, MD

More Information

Sponsor

Phraxis, Inc.

Last update posted

Jan 21, 2026

Last verified

Jan, 2026

Keywords

  • Hemodialysis
  • Arteriovenous graft

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Phraxis, Inc. on 2026-01-21.