The Motiva Implants clinical study is a single arm, multi-center trial, designed to measure the safety and effectiveness of the Motiva Implants SmoothSilk®/SilkSurface® and Ergonomix® in subjects who are undergoing primary breast augmentation, primary breast reconstruction, or revision surgery. It is scheduled to start in the second quarter of 2018, pending Institutional Review Board approvals at all selected clinical sites. With a population size of approximately 750 patients over 22 years in age and in up to 40 study sites in the United States, Canada, Sweden, and Germany, subjects will be selected per a strict protocol according to FDA regulations.
Patients meeting the inclusion and exclusion criteria may be enrolled in the study. The primary safety endpoint is based on the incidence, severity, method of resolution, and duration for all complications on a “per-implant” and “per-subject” basis. The use of 3D imaging systems, such as Divina®, performed pre-operatively and at 1-10 years visits, will supplement the data and corroborate the manual measurements performed. An MRI sub-study will be done in parallel to determine the percentage of ruptures, with a subset of the treated population selected to obtain MRIs at 1,2,4,6,8 and 10 years.
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