🏛️ Verified NIH Record • Updated 2025-12-05

Melodi Matrix™ in Breast Reconstruction (NCT06027996)

Absorbable Antibacterial Soft Tissue Support in Breast Reconstruction With Infection Outcomes Assessment (ARIA)

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Melodi Health, Inc.

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

Prospective, multicenter, randomized, controlled trial evaluating the safety and effectiveness of an absorbable antibacterial matrix device in two stage prepectoral alloplastic breast reconstruction.

Who can join: Review the eligibility criteria below.

Location: Stanford University — Palo Alto, California

Age range: 22 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 (10 Sites)

  • Stanford University — Palo Alto, California
  • University of Michigan Health — Ann Arbor, Michigan
  • Mayo Clinic — Rochester, Minnesota
  • Northwell Health — Staten Island, New York
  • The Ohio State University — Columbus, Ohio
  • UPMC — Pittsburgh, Pennsylvania
  • Medical University of South Carolina — Charleston, South Carolina
  • Monument Health — Rapid City, South Dakota
  • MD Anderson Cancer Center — Houston, Texas
  • University of Utah — Salt Lake City, Utah

📞 Contact the Study Coordinator

Phone: (210) 279-0194

Email: michele.hilmer@melodihealth.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 ↗