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

ConditionDevice Safety
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorEstablishment Labs

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 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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Primary gluteal enhancement

Treatment groups

120 Participants
are divided into 1 treatment group

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Establishment LabsRecruiting20101, Alajuela, Provincia de San JoséCosta RicaCosta Rica

Sponsors and collaborators