Motiva Flora® Aesthetic Breast Recon® Clinical Study (NCT06146231)
Motiva Flora® Tissue Expander as a Support for the Creation of an Autologous Adipose Matrix for Hybrid Breast Reconstruction: a Pivotal Study
🩺 Plain-English Summary (8th-Grade Level)
The present study will be based on a hybrid breast reconstruction approach with initial skin expansion using the Motiva Flora® Tissue Expander followed by a serial fat grafting session and a final step that includes the placement of a permanent breast implant Ergonomix2®.
Who can join: Review the eligibility criteria below.
Location: Universitair Ziekenhuis Gent — Ghent
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (4 Sites)
- Universitair Ziekenhuis Gent — Ghent,
- Hospital Universitario San Ignacio — Bogotá,
- Hospital UNIBE — San José,
- Hospital de la Santa Creu i Sant Pau — Barcelona,
📞 Contact the Study Coordinator
Phone: +34649713486
Email: lpalma@establishmentlabs.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.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.