EndoForce Post Approval Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-13

Study Completion Date

2029-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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End Stage Renal Disease (ESRD)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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EndoForce

AV Graft implanted using the EndoForce Connector for Endovascular Venous Anastomosis

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No