Clinical Trial

Motiva Flora Tissue Expander PMCF

Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated August 27, 2024 (before its estimated December 15, 2024 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2022-07-06; most recent amendment 2024-08-26.
Trial Details
NCT Number NCT05447988
Lead Sponsor Establishment Labs
Conditions Breast Tissue Accessory, Breast Cancer
Enrollment 136 participants
Start Date 2020-12-14
Primary Completion 2024-12-15 (estimated)
Study Completion 2026-07-15 (estimated)
Updated on ClinicalTrials.gov 2024-08-27