Adaptive Study to Assess the Safety and Functioning of Motiva Devices on Minimally Invasive Gluteal Augmentation

Recruiting N/A Interventional Study
Device Safety
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Other
Participants needed
120 (estimated)
Sponsor
Establishment Labs · Industry
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About This Trial
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…
Trial Locations
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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 estimatin…
Contacts

Jorge Villalobos Alpizar, MD

+506 8839-6446

jvillalobosa@establishmentlabs.com

CONTACT

Laura Garcia Jimenez

+506 8997-2767

lgarcia@establishmentlabs.com

CONTACT