EndoForce Post Approval Study
Recruiting
Observational Study
End Stage Renal Disease (ESRD)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 150 (estimated)
- Sponsor
- Phraxis, Inc. · Industry
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About This Trial
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.
Trial Locations
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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 stu…
Contacts