Study to Evaluate Safety and Function of Motiva Devices for Minimally Invasive Buttock Enhancement in Adult Women

What this Trial Is About

Researchers are evaluating the initial safety and performance of several Motiva devicesincluding the Ergonomix2Diamond, Motiva Injector, Motiva Inflatable Balloon, Reusable Channel Dissector, and GEM Channel Separatorused in a minimally invasive gluteal buttock augmentation procedure. This study involves 120 healthy adult female participants and aims to understand the side effects, procedural success, surgeon and participant satisfaction, and device functioning over a 24-month follow-up period. The study is adaptive, allowing adjustments based on ongoing safety and satisfaction data. Participants will undergo a minimally invasive buttock enhancement using the Motiva devices mentioned above, which are typically used in chest procedures but are being studied here for off-label use in the gluteal area. The study includes two stages a feasibility stage and a pivotal stage, with interim analyses every six months to monitor complications and satisfaction. The procedure is intended to restore the aesthetic curve of the back, and the devices assist in tissue dissection and implant placement. During the study, participants will attend follow-up visits over 24 months to assess outcomes and monitor safety. Researchers will evaluate safety and performance outcomes, including any side effects or procedural failures, and measure satisfaction from both surgeons and participants. The study also verifies the proper functioning of the Zen microtransponder device. Regular assessments will ensure close monitoring of participant health and device operation throughout the study period.

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