CompletedNot Applicable

Mia® Clinical Study

Costa Rica100 participantsStarted 2020-12-03

Plain-language summary

This study will follow 100 women over 36 months (3 years) to evaluate how safe and effective a minimally invasive breast augmentation procedure is. The women will have their first breast augmentation surgery using Motiva® Ergonomix2 Diamond® implants, Motiva Injector® and Motiva® Inflatable Balloon.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 imag…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety

Timeframe: From minimally invasive procedure through study completion, an average of 3 years.

Effectiveness

Timeframe: From minimally invasive procedure through study completion, an average of 3 years.

Trial details

NCT IDNCT06792409

SponsorEstablishment Labs

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-08

View on ClinicalTrials.gov More Breast Augmentation trials