NCT05447988

Motiva Flora Tissue Expander PMCF

Post-Marketing Clinical Follow-Up Study to Confirm the Safety and Effectiveness/Performance of Motiva Flora® Tissue Expander in Staged Breast Reconstruction Surgery

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: Establishment Labs · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Tissue Accessory
• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Breast Tissue Expander	tissue expander based breast reconstruction

Timeline

• Start date: 2020-12-14
• Primary completion: 2024-12-15
• Completion: 2026-07-15
• First posted: 2022-07-07
• Last updated: 2024-08-27

Locations

5 sites across 4 countries: Chile, Costa Rica, Panama, Spain