RecruitingNot ApplicableNCT06146231

Motiva Flora® Aesthetic Breast Recon® Clinical Study

Motiva Flora® Tissue Expander as a Support for the Creation of an Autologous Adipose Matrix for Hybrid Breast Reconstruction: a Pivotal Study

Sponsor

Establishment Labs

Enrollment

66 participants

Start Date

Aug 18, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Mammaplasty Poland Syndrome

Summary

The present study will be based on a hybrid breast reconstruction approach with initial skin expansion using the Motiva Flora® Tissue Expander followed by a serial fat grafting session and a final step that includes the placement of a permanent breast implant Ergonomix2®.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical study evaluates the Motiva Flora® device — a new type of tissue expander used for breast reconstruction — in women who have had a mastectomy (breast removal surgery) for breast cancer. **You may be eligible if...** - You are a genetically female adult (18 or older) who needs breast reconstruction after mastectomy - You have completed radiotherapy and chemotherapy at least one year before surgery - Your BMI is between 18.5 and 30 - You have sufficient body fat for tissue expansion - You are physically and mentally able to follow the surgical team's instructions and attend follow-up visits **You may NOT be eligible if...** - You are currently pregnant or breastfeeding - You have abnormal lab results after chemotherapy - You are considered high surgical risk - You have metastatic (spread) breast cancer - There are tumor cells remaining near the area for reconstruction - Your breast skin is poor quality - You have previously had a breast reconstruction attempt - You have an autoimmune disease (e.g., lupus, scleroderma) or are immunosuppressed - You are an active smoker - You have a history of silicone sensitivity - You cannot have an MRI scan 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.

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Interventions

DEVICEMotiva Flora® Tissue Expander

This hybrid breast reconstruction involves a stage in which the tissue expander (Motiva Flora®) is used as intended for a conventional expansion. After achieving the desired volume, it is deflated in a controlled way to proceed with the execution of serial fat grafting procedures (reverse expansion). This also means the expander is implanted longer than indicated on its current Directions For Use. Once the reverse expansion is complete, the expander is replaced with a long-term breast implant. Motiva Implants Ergonomix2® Sterile Silicone Breast Implants will be used as per Standard of Care under the CE marked indication. To obtain the safest, most natural, and aesthetic outcomes, Ergonomix2® breast implants have been selected as the standard silicone breast implants for this study.