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Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05447988
Study type Interventional
Source Establishment Labs
Contact Catalina Solano
Phone +506-83112829
Email csolano@establishmentlabs.com
Status Recruiting
Phase N/A
Start date December 14, 2020
Completion date July 15, 2026

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