66
Participants
Start Date
August 18, 2023
Primary Completion Date
April 30, 2024
Study Completion Date
April 30, 2027
Motiva Flora® Tissue Expander
"This hybrid breast reconstruction involves a stage in which the tissue expander (Motiva Flora®) is used as intended for a conventional expansion. After achieving the desired volume, it is deflated in a controlled way to proceed with the execution of serial fat grafting procedures (reverse expansion). This also means the expander is implanted longer than indicated on its current Directions For Use. Once the reverse expansion is complete, the expander is replaced with a long-term breast implant.~Motiva Implants Ergonomix2® Sterile Silicone Breast Implants will be used as per Standard of Care under the CE marked indication.~To obtain the safest, most natural, and aesthetic outcomes, Ergonomix2® breast implants have been selected as the standard silicone breast implants for this study."
RECRUITING
Universitair Ziekenhuis Gent, Ghent
NOT_YET_RECRUITING
Hospital Universitario San Ignacio, Bogotá
NOT_YET_RECRUITING
Hospital UNIBE, San José
RECRUITING
Hospital de la Santa Creu i Sant Pau, Barcelona
Collaborators (1)
NAMSA
OTHER
Establishment Labs
INDUSTRY