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EndoForce Post Approval Study

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
South Carolina
MUSC Health Orangeburg
NOT_YET_RECRUITING
Orangeburg
Spartanburg Regional Medical Center
RECRUITING
Spartanburg
Contact Information
Primary
John Zentgraf
jzentgraf@phraxis.com
651-260-6673
Time Frame
Start Date: 2026-01-13
Estimated Completion Date: 2029-12
Participants
Target number of participants: 150
Treatments
EndoForce
AV Graft implanted using the EndoForce Connector for Endovascular Venous Anastomosis
Related Therapeutic Areas
Sponsors
Leads: Phraxis, Inc.

This content was sourced from clinicaltrials.gov