Safety and Performance of Motiva® Sizers

Launched by ESTABLISHMENT LABS · Feb 15, 2024

Keywords

ClinConnect Summary

The Motiva® Sizer clinical trial is studying the safety and effectiveness of a new device called the Motiva® Sizer, which is used during breast augmentation or reconstruction surgeries. The trial will involve 330 women, with half receiving the Motiva® Sizer and the other half having the surgery without it. Researchers want to see if using the Motiva® Sizer leads to fewer complications, higher satisfaction for both the surgeons and the patients, and whether it affects the need for any follow-up surgeries.

To participate in this study, women must be at least 18 years old and planning to undergo breast surgery. They should have enough tissue to safely cover the implants and agree to attend all follow-up appointments for the next three years. However, there are some reasons a woman might not be eligible, such as certain medical conditions or recent breast infections. Participants can expect regular check-ins after surgery to monitor their recovery and any potential issues. This study is taking place in Costa Rica, and it aims to provide valuable information about the Motiva® Sizer's performance in real-world settings.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Female, 18 years of age or older.
• • The participant will be undergoing a breast augmentation or reconstruction procedure.
• • To possess enough and adequate tissue to cover the implants.
• • Willingness to comply with all study requirements, including signing the informed consent document and agreeing to attend all required follow-up visits.
• Exclusion Criteria:
• • Existing rib injuries.
• • Inadequate or unsuitable tissue for augmentation or reconstruction surgery at the physician's discretion.
• • History of abscesses or infections in the breast area.
• • Current pregnancy or breastfeeding, or full-term pregnancy or breastfeeding in the six months prior to enrollment.
• • History of sensitivity to silicone.
• • Any medical condition, such as underweight or obesity, diabetes, autoimmune disease or severe chronic pulmonary or cardiovascular disease, psychological/psychiatric disorders that may result in unduly high surgical risk and/or significant postoperative complications.
• • Active or recurrent breast cancer.
• • Consumption of any medication that, in the investigator's experience, may pose an increased risk of complications or interfere with wound healing ability, such as corticosteroid therapy or blood clotting medication (e.g., concomitant treatment with warfarin).
• • Not living in the country where the procedure was performed , which prevents him/her from attending follow-up visits .