Evaluation of STARgraft-3 for Hemodialysis - Trial NCT05729620
Access comprehensive clinical trial information for NCT05729620 through Pure Global AI's free database. This phase not specified trial is sponsored by Healionics Corporation and is currently Recruiting. The study focuses on End Stage Renal Disease. Target enrollment is 15 participants.
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Study Focus
Implant of STARgraft-3 shunt in the upper arm and subsequent use for hemodialysis access
Interventional
device
Sponsor & Location
Healionics Corporation
Timeline & Enrollment
N/A
Nov 29, 2022
Jul 01, 2024
Primary Outcome
Primary Unassisted Patency
Summary
This study is a single site, prospective, single arm evaluation of the safety and
 effectiveness of the Healionics STARgraft-3 hemodialysis access graft. STARgraft devices have
 been demonstrated in preclinical and other studies to have improved resistance to the common
 failure modes of venous anastomosis stenosis and infection.
 
 This study is an extension from prior studies with STARgraft AV (NCT03916731) and STARgraft-2
 (NCT04783779) investigational devices. A previous study also included control implants of
 commercially available standard ePTFE grafts approved for the same use.
 
 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-3 compared to the ePTFE controls in the prior study and to
 published results, over a period of 6 months, with extended results to 1 year.
 
 Estimated enrollment is 15 subjects in this study.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05729620
Device Trial