Single-arm multicenter interventional clinical trial of buttock augmentation with polymethyl methacrylate. The objective is to evaluate the safety and effectiveness of using 30% Biosimetric PMMA gel for buttock augmentation.
The sample will be 133 patients. Specific patients will be screened at study sites according to eligibility classifications. After signing the consent form, patients will be included in the study and will be monitored for 9 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
133
PMMA 30%
Number of participants with treatment-related adverse events as assessed by clinical evaluation
Occurrence of adverse events in patients who underwent gluteal augmentation with 30% Biosymmetric PMMA. Expected events will be classified as adverse events when they persist for more than two weeks, and should be reported throughout the study. Adverse events not previously identified will also be monitored at all visits.
Time frame: Before application of PMMA and 6 and 9 months after the procedure
Changes in normal values of laboratory biochemical tests
laboratory biochemical exams
Time frame: Before application of PMMA and 6 and 9 months after the procedure
Volumetric capacity of filled muscle assessed by ultrasound imaging
Using an ultrasound device, images of the gluteus will be obtained to analyze the thickness of the muscle, and thus estimate its volumetric capacity.
Time frame: Before application of PMMA and 6 and 9 months after the procedure
Physician satisfaction assessed by GAIS scale
Physician satisfaction will be assessed using the Portuguese version of the Global Aesthetic Improvement Scale, assigning values according to the following parameters: Much improved (5): excellent cosmetic result after the procedure. Much improved (4): marked improvement in appearance from the initial condition, but not completely optimal for the patient. Better (3): obvious improvement in appearance from the initial condition. Unchanged (2): appearance is essentially the same as the original condition. Worse (1): appearance is worse than the original condition.
Time frame: Before application of PMMA and 4, 6 and 9 months after the procedure
Patient satisfaction assessed by GAIS scale
Patient satisfaction will be assessed using the Portuguese version of the Global Aesthetic Improvement Scale, assigning values according to the following parameters: Much improved (5): excellent cosmetic result after the procedure. Much improved (4): marked improvement in appearance from the initial condition, but not completely optimal for the patient. Better (3): obvious improvement in appearance from the initial condition. Unchanged (2): appearance is essentially the same as the original condition. Worse (1): appearance is worse than the original condition.
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Time frame: Up to 4, 6 and 9 months after the procedure