Motiva devices for minimally invasive buttock augmentation

Adaptive Study to Assess the Initial Safety and Functioning of the Minimally Invasive Gluteal Augmentation Procedure and Its Devices in Participants Undergoing Primary Gluteal Enhancement

This trial will see if Motiva devices used off-label are safe and work well for minimally invasive buttock enhancement in healthy adult women.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Establishment Labs (industry)
• Drugs / interventions: radiation
• Locations: 1 site (Alajuela, Provincia de San José)
• Trial ID: NCT07135011 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are cisgender women aged 18 or older, ASA class I–II, BMI 18.5–28, with no prior buttock augmentation or biopolymer injections, adequate local tissue coverage, and willingness to attend all follow-up visits.

Not a fit: Patients with massive weight loss, significant buttock ptosis or poor skin quality, inadequate tissue or compromised healing, current pregnancy, prior buttock infections, or other exclusion criteria may not receive benefit from this procedure.

Why it matters

Potential benefit: If successful, this approach could offer a less invasive buttock augmentation option with potentially fewer complications and faster recovery compared with traditional techniques.

How similar studies have performed: These Motiva devices have documented safety and performance in breast applications, but their use for gluteal augmentation is off-label and has limited published evidence to date.

Eligibility criteria

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 this trial is running

Alajuela, Provincia de San José

• 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

Conditions: Device Safety, Equipment safety, Buttock augmentation