NCT05459064

Retrospective Data Collection on the Use of Motiva Flora TE in Breast Reconstruction

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 144 (actual)
• Sponsor: Establishment Labs · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Motiva Flora® TE are intended for temporary subcutaneous or submuscular implantation to develop surgical flaps and additional tissue coverage and are not intended for use beyond six (6) months. All Motiva Flora® TE's require periodic, incremental inflation with sterile saline for injection until the desired tissue amount is developed. After the desired volume, the expander is surgically removed and replaced with a long-term breast implant in the same space as the tissue expander. The study collects retrospective data on the use of the Motiva Flora TE, from patients who had a tissue expander-based-breast reconstruction using the Motiva Flora® TE since market introduction in May 2020.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Motiva Flora TE	This is a retrospective, observational study - collecting data on patients who have gone through the staged procedure with the Motiva Flora Tissue Expander / Long-term breast implant.

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2022-07-14
• Last updated: 2024-08-27

Locations

2 sites across 2 countries: Belgium, Spain