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Multi-Site STARgraft (10401) Trial

NCT07557862 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2026-08-13

No results posted yet for this study

Summary

This is a multi-site, single-blind with parallel group, randomized controlled trial of Healionics STARgraft (10401) vascular graft for hemodialysis access compared with a market-leading commercially available ePTFE vascular graft (Gore Propaten Vascular Graft).

Conditions

  • End Stage Renal Disease (ESRD)

Interventions

DEVICE

STARgraft (10401)

Device: STARgraft (10401) Surgical implantation of STARgraft (10401) for Hemodialysis in the upper forearm.

DEVICE

Gore Propaten

Device: Gore Propaten Surgical implantation of Gore Propaten for Hemodialysis in the upper forearm.

Sponsors & Collaborators

  • Healionics Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2027-06-30
Completion
2029-06-30
FDA Device
Yes

Countries

  • Brazil
  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07557862 on ClinicalTrials.gov