Condition: Breast Tissue Accessory · Breast Cancer · Sponsor: Establishment Labs
The Motiva Flora® Tissue Expander clinical study (hereafter Motiva Flora® TE study) is a 6-month, open-label, prospective, multicentre post-marketing follow-up study designed to confirm the Safety and Effectiveness/Performance of Motiva Flora® TE in breast reconstruction surgery. The study will include 136 women, planned for staged breast reconstruction, in 6 countries (Spain, Belgium, France, Costa Rica, Chile and Panama). Breast tissue expansion and the final breast implant will be performed using devices from the Motiva Flora® TE catalogue.
This description comes directly from the study's public registry record.
Catalina Solano · +506-83112829 · csolano@establishmentlabs.com
Jorge Villalobos · +506-8839 6446 · jvillalobosa@establishmentlabs.com
Always discuss trial participation with your own doctor first.
| Centro de Cirugía Plástica y Reconstructiva. Dra. Viviana Spröhnle Hospital Regional de Rancagua | Rancagua, Chile | Recruiting |
| Centro Europeo de Cirugia | San José, Provincia de San José, Costa Rica | Recruiting |
| The Panama Clinic Complejo Hospitalario Pacific Center | Panama City, Panama | Recruiting |
| Centro de Patología de la Mama | Madrid, Spain | Recruiting |
| Hospital Gregorio Marañón | Madrid, Spain | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05447988