Actively Recruiting
Adaptive Study to Assess the Safety and Functioning of Motiva Devices on Minimally Invasive Gluteal Augmentation
Led by Establishment Labs · Updated on 2025-08-21
120
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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, and Motiva® GEM Channel Separator utilized in a minimally invasive gluteal augmentation procedure, involving 120 healthy female participants. The main questions it aims to answer are: * Are the main side effects and complications experienced by participants who underwent a minimally invasive buttock enhancement procedure with Motiva Ergonomix2® Diamond®, the Motiva Injector®, the Motiva® Inflatable Balloon, the Motiva® Reusable Channel Dissector, and Motiva® GEM Channel Separator adequately characterized? * Can the Motiva Injector®, Motiva® Inflatable Balloon, the Motiva® Reusable Channel Dissector, and Motiva® GEM Channel Separator be successfully utilized, and are any failures in the process detected? * Does the Motiva® GEM Channel Separator effectively perform tissue dissection procedures without experiencing operational dysfunctions? * Are both the surgeon and the participant satisfied with the procedure outcomes? * Is the proper functioning of the Zen microtransponder verified? Participants will undergo a minimally invasive buttock enhancement procedure using the Ergonomix2® Diamond®, the Motiva Injector®, the Motiva® Inflatable Balloon, the Motiva® Reusable Channel Dissector, and Motiva® GEM Channel Separator, and have a follow-up of 24 months to see the results.
CONDITIONS
Official Title
Adaptive Study to Assess the Safety and Functioning of Motiva Devices on Minimally Invasive Gluteal Augmentation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cisgender women aged 18 years or older
- No prior buttock augmentation or biopolymer injections in the buttocks
- Classified as ASA class I or II for surgical risk
- Seeking buttock enhancement to restore aesthetic curvature
- Body mass index between 18.5 and 28
- Adequate tissue to cover the implant(s)
- Willing to comply with study requirements and attend all follow-up visits
- Agree to return the device to the sponsor if explanted
You will not qualify if you...
- Women with massive weight loss
- Buttock ptosis or poor skin quality
- Inadequate tissue due to radiation damage, ulceration, compromised vascularization, or healing history
- Current pregnancy
- History of abscesses or infections in the buttock area
- History of sensitivity to silicone
- Medical conditions causing high surgical risk or complications, such as underweight, obesity outside criteria, diabetes, autoimmune disease, severe chronic pulmonary or cardiovascular disease
- Unrealistic psychological expectations regarding surgery risks
- Use of medications that increase risk or affect healing, such as corticosteroids or blood thinners
- Not residing in the Great Metropolitan Area of Costa Rica, limiting follow-up attendance
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Establishment Labs
Alajuela, Provincia de San José, Costa Rica, 20101
Actively Recruiting
Research Team
J
Jorge Villalobos Alpizar, MD
CONTACT
L
Laura Garcia Jimenez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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