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EndoForce Post Approval Study for Hemodialysis Grafts

This study is looking at the long-term safety and performance of the EndoForce System. This system helps connect a hemodialysis graft (a tube placed under your skin to allow for dialysis) to a vein in people with End Stage Renal Disease (ESRD), which is permanent kidney failure. The EndoForce System is already approved by the FDA, so this is not an experimental treatment. The study will follow 150 participants to see how well the grafts work over two years and if there are any side effects. You may be able to join if you are 18 or older, need a vascular access graft for hemodialysis in your upper arm, and are able to follow the study's requirements. The current recruitment status is unclear.

Study design
This is an observational study, meaning researchers will watch and collect information without providing new treatments. It plans to include 150 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for two years to track the graft's performance and any side effects.

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NCT07146854

EndoForce Post Approval Study

Recruiting
Not specifiedAges 18+Observational
Phraxis, Inc.
~150 participants
Updated 2026-01-21 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Treatment-Emergent Adverse Events
Measured over 2 years
+4 more outcomes measured

Conditions

End Stage Renal Disease (ESRD)

Explore related trials

Chronic Kidney Disease, Stage 5

Where it's being run

2 sites across 1 states
South Carolina2

Study leadership

  • Ari Kramer, MD · PRINCIPAL_INVESTIGATOR · Spartanburg Regional Medical Center

Who to contact

John Zentgraf
[email protected]
651-260-6673
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 this trial measures

  • Incidence of Treatment-Emergent Adverse Events2 years

    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.

  • AVG Cumulative Patency2 years

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

  • AVG Primary Patency2 years

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

  • Number of AVG Interventions to Maintain Patency2 years

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

  • Number of Participants with Acute Device SuccessThrough end of procedure

    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.