U.S., March 1 -- ClinicalTrials.gov registry received information related to the study (NCT06851494) titled 'Safety and Efficacy of Linnea Safe PMMA 30% Use for Gluteal Augmentation.' on Feb. 24.
Brief Summary: This pre-market, interventional, single-arm study aims to evaluate the safety and efficacy of LinneaSafe 30% polymethylmethacrylate (PMMA) for gluteal augmentation. The study will include 119 patients, with a total recruitment of 137 to account for a 15% drop-out rate. Eligible participants are men and women over 18 years old who express interest and are deemed suitable for the procedure. The primary safety outcome is the incidence of adverse events, while the primary efficacy outcome is patient satisfaction.
Study Start Date: Nov....