Motiva devices for minimally invasive buttock augmentation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a 24-month, prospective, open-label interventional study enrolling about 120 healthy cisgender women to test several Motiva devices applied off-label for gluteal augmentation. The study uses an adaptive two-stage design (feasibility then pivotal) with preplanned interim analyses every six months to monitor safety and device performance. Investigators will record adverse events, characterize complications, and document device use success or failures during the minimally invasive procedure. Follow-up visits are required to track outcomes and any device-related issues over time.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Cisgender women, aged 18 years or older.
* Participants without prior buttock augmentation or biopolymer injections in the buttocks.
* Participants classified as ASA class I and II according to the American Society of Anesthesiologists (ASA) classification system for estimating risk.
* Participants seeking buttock enhancement, aiming to simply restore the aesthetic curvature of the back.
* Body mass index between 18.5 and 28.
* Adequate tissue available to cover the implant(s).
* Willingness to comply with all study requirements and agree to attend all required follow-up visits.
* Agreement to return the device to the sponsor in case of explantation.

Exclusion Criteria:

* Women with massive weight loss.
* Buttock ptosis or poor skin quality.
* Inadequate tissue (e.g., due to radiation damage, ulceration, compromised vascularization, history of compromised healing).
* Current pregnancy.
* History of abscesses or infections in the buttock area.
* History of sensitivity to silicone.
* Any medical condition such as underweight or obesity according to inclusion criteria, diabetes, autoimmune disease, or severe chronic pulmonary or cardiovascular disease resulting in excessively high surgical risk and significant postoperative complications.
* History of psychological characteristics that are unrealistic or unreasonable given the risks associated with the surgical procedure.
* Use of any medication that, according to the investigator's experience, may pose a higher risk of complications or interfere with wound healing capacity, such as corticosteroid treatment or blood-thinning medications (e.g., concomitant treatment with warfarin).
* Participants who do not reside in the Great Metropolitan Area of Costa Rica, which makes it difficult for them to attend follow-up visits.

Where it's running

• Establishment Labs
  Alajuela, Provincia de San José, Costa Rica Recruiting

Study contacts

• Principal investigator: Adolfo Ortiz Barboza, MD — Principal Investigator
• Study coordinator: Jorge Villalobos Alpizar, MD
• Email: jvillalobosa@establishmentlabs.com
• Phone: +506 8839-6446

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Hybrid breast reconstruction using Motiva Flora® Tissue Expander

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  Recruiting at 2 sites Establishment Labs · Ghent and 3 other locations · NCT06146231

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.