| NCT ID | NCT07146854 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Phraxis, Inc. |
| Condition | End Stage Renal Disease (ESRD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-01-13 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2026-01-13 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Ari Kramer, MD
PRINCIPAL INVESTIGATOR
Spartanburg Regional Medical Center
Frequently Asked Questions
Who can join the NCT07146854 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying End Stage Renal Disease (ESRD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07146854 currently recruiting?
Yes, NCT07146854 is actively recruiting participants. Contact the research team at jzentgraf@phraxis.com for enrollment information.
Where is the NCT07146854 trial being conducted?
This trial is being conducted at Orangeburg, United States, Spartanburg, United States.
Who is sponsoring the NCT07146854 clinical trial?
NCT07146854 is sponsored by Phraxis, Inc.. The principal investigator is Ari Kramer, MD at Spartanburg Regional Medical Center. The trial plans to enroll 150 participants.