Status:
RECRUITING
Adaptive Study to Assess the Safety and Functioning of Motiva Devices on Minimally Invasive Gluteal Augmentation
Lead Sponsor:
Establishment Labs
Conditions:
Device Safety
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The objective of this clinical trial is to assess the initial performance and safety of Motiva® Ergonomix2® Diamond®, Motiva Injector®, Motiva® Inflatable Balloon, Motiva® Reusable Channel Dissector, ...
Detailed Description
This is a prospective, open-label, interventional study lasting 24 months, aimed at evaluating the safety and performance of Motiva® Ergonomix2® Diamond®, Motiva Injector®, Motiva® Inflatable Balloon,...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07135011
Start Date
April 12 2023
End Date
April 1 2026
Last Update
August 21 2025
Active Locations (1)
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1
Establishment Labs
Alajuela, Provincia de San José, Costa Rica, 20101