NCT07146854 · Phraxis, Inc.
EndoForce Post Approval Study
What this study is about
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.
View original scientific description
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.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events
Time frame: 2 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 Patency
Time frame: 2 years
The percentage of subjects free from loss of access of the study graft for hemodialysis.
AVG Primary Patency
Time frame: 2 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 Patency
Time frame: 2 years
The number of AVG interventions until access abandonment or through study completion.
Number of Participants with Acute Device Success
Time frame: Through 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Orangeburg, South Carolina
- Spartanburg, South Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 21, 2026 · Source of record for eligibility and locations