Mia® Clinical Study

Launched by ESTABLISHMENT LABS · Jan 20, 2025

Keywords

ClinConnect Summary

This is a prospective follow-up, 36-month, open, interventional study to confirm the safety and effectiveness of the procedure and system devices, including Motiva® Ergonomix2 Diamond® implants in women subjected to primary breast augmentation.

This study will enroll 100 women who will undergo a minimally invasive breast augmentation procedure with Ergonomix2 Diamond® using Motiva Injector® MIA and the Motiva MIA® inflatable balloon. The study duration will be 36 months and a six-month enrollment window was planned.

Recruitment will take place after enrollment and before any clinical rese...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Genetic females, ≥ 18 years.
• • AA to C cup size, evaluated according to Triumph international guidelines.
• • Participants with Class I and II risk according to the American Society of Anesthesiologists (ASA)
• • Participants seeking a primary breast augmentation to increase the size of their breasts by one cup size.
• • Body Mass Index between 18.5 and 24.9 (normal weight).
• • Adequate tissue for covering the implant(s).
• • Willingness to follow all study requirements and attending all necessary follow-up visits.
• • Agreement to return the device to the sponsor in case it is explanted
• Exclusion Criteria:
• • Current costal lesions.
• • Breast ptosis or poor skin quality.
• • Inadequate tissue (for example, radiation damage, ulcers, compromised vascularity, history of inadequate wound scaring).
• • History of abscesses or infections in the breast area.
• • Currently pregnant or breastfeeding, or pregnancy or breastfeeding to term in the six months prior to recruitment.
• • History of silicone sensitivity.
• • Use of any medications that interfere with coagulation or that may imply a high risk and/or significant post-surgical complication.
• • Any medical condition, such as low weight or obesity according to the inclusion criteria, diabetes, autoimmune disease, chronic lung disease or serious cardiovascular disease that may result in an excessively high surgical risk and/or important post-surgical complications.
• • Any condition that precludes the use of magnetic resonance imaging (MRI), including implanted metal devices, claustrophobia or other conditions that preclude MRI exploration.
• • Any history of psychological characteristics that are not realistic or reasonable, considering the risks involved with the surgical procedure.
• • Use of any medications that, according to the investigator, may imply a higher risk of complications or interference with wound healing ability, such as corticosteroids or anticoagulants (i.e., concomitant warfarin therapy).
• • Current participation on studies for investigation devices or pharmaceutical products.
• • Participants not residing in Costa Rica, which precludes their attendance to follow-up visits.
• • Sponsor (or any of its subsidiaries) employees, study investigator or any person helping to conduct the study; direct (family) relationship with any sponsor (or any of its subsidiaries) or investigator employees.