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NCT05729620Recruiting

Evaluation of STARgraft-3 for Hemodialysis

Healionics CorporationClinicalTrials.govdeviceDevice trial
Verified
Study focus
Disease/Condition
End Stage Renal Disease
Drug/Device/Intervention
Implant of STARgraft-3 shunt in the upper arm and subsequent use for hemodialysis access
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Healionics Corporation
Location
Asunción, Paraguay
Timeline & enrollment
Phase
N/A
Start date
Nov 29, 2022
End date
Jul 01, 2024
Enrollment
15 participants
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
Chronic kidney disease, stage 1Chronic kidney disease, stage 5Chronic kidney disease, stage 2Chronic kidney disease, stage 3Chronic kidney disease, stage 4
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05729620
Type
Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.