RecruitingNot ApplicableNCT07555717

STARgraft (10401) Pilot

STARgraft Vascular Graft 10401 for Hemodialysis Access Pilot

Sponsor

Healionics Corporation

Enrollment

20 participants

Start Date

Jan 29, 2026

Study Type

INTERVENTIONAL

Conditions

End Stage Kidney Disease (ESRD)

Summary

This study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft (10401) hemodialysis access graft. The study is enrolling patients with End Stage Renal Disease (ESRD) requiring hemodialysis via a prosthetic vascular graft. The study proposes to evaluate the performance of the investigational STARgraft (10401) compared to the ePTFE controls in a prior study (NCT03916731) and to published results, over a period of 6 months. Additional data out to 36 months post-implantation may be captured.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called STARgraft (10401) for people with end stage kidney disease (esrd). The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESTARgraft (10401)

Participants will be implanted with 6mm diameter STARgraft (10401) grafts as an upper arm Brachial Artery to Axillary Vein shunt for hemodialysis access.