NCT07135011

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Establishment Labs · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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, Motiva® Reusable Channel Dissector, and Motiva® GEM Channel Separator utilized in a minimally invasive gluteal augmentation procedure. The devices included in this study are indicated for use in the chest area. According to an ongoing study, their safety and performance have been demonstrated. It is not expected that the off-label use of Ergonomix2® Diamond®, Motiva Injector®, Motiva® Inflatable Balloon, Motiva® Reusable Channel Dissector, and Motiva® GEM Channel Separator in the gluteal area will increase any risks or potential harm to the participants. On the contrary, the minimally invasive procedure is expected to provide more positive and safer outcomes. This study has been designed as an adaptive study since the devices to be used are not indicated for use in the gluteal area. This allows for careful evaluation of real-time clinical data to make decisions regarding clinical development. This study will consist of two stages: the feasibility stage and the pivotal stage. It involves the decision to progress participant recruitment from the feasibility phase to the pivotal phase, as long as there are no unknown complications, serious incidents, or incidents not previously described in available literature. A pre-planned interim analysis will be conducted every 6 months. It will analyze enrolled participants, their complications, and satisfaction. The collected data will be considered to decide transition stages. The scope of the adaptive design is to combine these two stages of clinical development to: * Maximize trial information * Shorten development timelines * Reduce risk for study participants and the sponsor * Regulatory advantages For this study, 120 women will be recruited according to the study's requirements from different countries in Latin America to undergo a minimally invasive gluteal enhancement procedure using Ergonomix2® Diamond®, Motiva Injector®, Motiva® Inflatable Balloon, Motiva® Reusable Channel Dissector, and Motiva® GEM Channel Separator. The study period will last up to 24 months, and recruitment is expected to last up to six months.

Conditions

• Device Safety

Interventions

Type	Name	Description
DEVICE	Primary gluteal enhancement	120 participants will undergo primary buttock enhancement procedures utilizing the Ergonomix2® Diamond®, Motiva Injector®, Motiva® Inflatable Balloon, Motiva® Reusable Channel Dissector, and Motiva® GEM Channel Separator devices.

Timeline

• Start date: 2023-04-12
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2025-08-21
• Last updated: 2025-08-21

Locations

1 site across 1 country: Costa Rica