Buttock Augmentation With Polymethylmethacrylate
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-60
SponsorMTC MEDICAL COMERCIO INDUSTRIA IMPORTACAO E EXPORTACAO DE PRODUTOS BIOMEDICOS LTDA
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age between 18 and 60 years old;
Signed Informed Consent Form (ICF);
Participant understands and is willing to participate in the clinical study and attend visits.
Disqualifiers
Known history of allergy to formula components;
Have the following morbidities (or any other disease that may interfere with the study): chronic inflammatory disease, immunosuppression, diabetes, hypertension, autoimmune disease, dermatological disease in the region to be treated, acute or chronic renal failure, history of coronary disease, history of cerebrovascular disease, current neoplasia, mental illness undergoing psychiatric treatment, obesity with a BMI above 30, asthma, bronchitis, seizures, hepatitis or other active infectious diseases;
Pregnancy;
Prior filling of glutes;
Trial design
Design model
Single group
Treatments tested in this trial
PMMA
DevicePMMA 30%
Treatment groups
133 Participants
are divided into 1 treatment groupGroup A: ExperimentalExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 procedureSecondary outcomes
1
Changes in normal values of laboratory biochemical tests
laboratory biochemical exams
Time frame
Before application of PMMA and 6 and 9 months after the procedure2
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 procedure3
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 procedure4
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.
Time frame
Up to 4, 6 and 9 months after the procedureLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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