Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT06851494
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.
Detailed Description:
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:
NCT06851494
Study Brief:
Protocol Section:
NCT06851494