NCT06146231

Motiva Flora® Aesthetic Breast Recon® Clinical Study

Motiva Flora® Tissue Expander as a Support for the Creation of an Autologous Adipose Matrix for Hybrid Breast Reconstruction: a Pivotal Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Establishment Labs · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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®.

Conditions

• Mammaplasty
• Breast Cancer
• Poland Syndrome

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2023-08-18
• Primary completion: 2026-04-01
• Completion: 2027-04-01
• First posted: 2023-11-24
• Last updated: 2025-11-26

Locations

4 sites across 4 countries: Belgium, Colombia, Costa Rica, Spain