RecruitingNot ApplicableNCT05447988

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

Sponsor

Establishment Labs

Enrollment

136 participants

Start Date

Dec 14, 2020

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Breast Tissue Accessory

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting long-term safety and effectiveness data on a new type of tissue expander (Motiva Flora) used in breast reconstruction after mastectomy — a device placed under the skin to gradually stretch the tissue before a permanent breast implant is placed. **You may be eligible if...** - You are female and 18 years or older - You need a tissue expander as part of breast reconstruction after mastectomy - You are in good enough health to have the expander placed, as determined by your surgeon - If you received radiation therapy, it was completed at least 1 year before surgery - You are willing and able to attend all follow-up visits **You may NOT be eligible if...** - You are not a candidate for breast implant placement - You have conditions that make breast reconstruction unsafe - You are unwilling to follow study requirements including follow-up visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.