🏛️ Verified NIH Record • Updated 2026-08-11

Multi-Site STARgraft (10401) Trial (NCT07557862)

Multi-Site Randomized Controlled Trial of STARgraft (10401) Vascular Graft for Hemodialysis Access

🟡 Not Yet Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Healionics Corporation

🩺 Plain-English Summary (8th-Grade Level)

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).

Who can join: Review the eligibility criteria below.

Location: Afya Hospital Dia, Brasília. — Brasília

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (7 Sites)

  • Afya Hospital Dia, Brasília. — Brasília,
  • Hospital Baía Sul — Florianópolis,
  • Royal Portuguese Beneficent Hospital in Pernambuco — Recife,
  • Pedro Ernesto University Hospital — Rio de Janeiro,
  • Hospital Ana Nery — Salvador,
  • Clinica Farallones — Cali,
  • Medellín Clinic - El Poblado — Medellín,

📞 Contact the Study Coordinator

Phone: (206) 432-9060

Email: ashleigh@healionics.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗