HomeTrialNCT07135011
🔬NCT07135011NARECRUITING

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

Study 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, 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
Interventions / Drugs
View on ClinicalTrials.gov ↗
Study Details
Enrollment120 participants
Primary Completion
Lead SponsorEstablishment Labs
Data Retrieved2026-04-11 04:13:11.670867+00:00
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