Lebon Chemical Products and Pharmaceuticals Ltda.
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.
Gluteal Augmentation
PMMA
NA
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. Patient recruitment will be conducted via social media. After signing the consent form, participants will undergo screening, including laboratory tests, gluteal ultrasound, and bioimpedance. The procedure (T0) involves baseline photos, gluteal measurements, and intramuscular PMMA augmentation (maximum 300 mL), followed by an evaluation of patient and clinician satisfaction. Follow-ups include online assessments at T1 week and T3 months to monitor adverse events. At T6 months, patients will undergo clinical evaluation, laboratory tests, photos, and satisfaction assessments, with the possibility of a retouch (up to 120 mL) if necessary, followed by an additional online check-up after one week. The final evaluation at T12 months will include photos, gluteal measurements, laboratory tests, ultrasound, bioimpedance, and an overall assessment of safety and efficacy.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 137 participants |
| Masking : | NONE |
| Primary Purpose : | OTHER |
| Official Title : | Safety and Efficacy of Linnea Safe PMMA 30% Use for Gluteal Augmentation. |
| Actual Study Start Date : | 2025-11-01 |
| Estimated Primary Completion Date : | 2026-11-01 |
| Estimated Study Completion Date : | 2026-11-01 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: | 1 |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
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