EndoForce Post Approval Study

Part of paid clinical trials in Orangeburg, South Carolina.

Sponsor
Phraxis, Inc.
Study ID
NCT07146854
Status
Recruiting
Apply to this trial

Conditions

  • End Stage Renal Disease (ESRD)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Jan 13, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: EndoForce
    AV Graft implanted using the EndoForce Connector for Endovascular Venous Anastomosis

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events [ Time Frame: 2 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
MUSC Health OrangeburgOrangeburgSouth Carolina29118
Virginia Anderson
[email protected]
803-395-3878
Mark London, MD (PRINCIPAL_INVESTIGATOR)
Spartanburg Regional Medical CenterSpartanburgSouth Carolina29303
Darla Howard
[email protected]
864-590-5521
Ari Kramer, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Orangeburg, SC

By research site
MUSC Health Orangeburg· Orangeburg, SCSpartanburg Regional Medical Center· Spartanburg, SC

Related Studies