Aesthetics, Augmentation
Conditions
Keywords
augmentation, gluteal
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPMMA
PMMA 30%
Sponsors
MTC MEDICAL COMERCIO INDUSTRIA IMPORTACAO E EXPORTACAO DE PRODUTOS BIOMEDICOS LTDA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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; * Use of acetylsalicylic acid, anti-inflammatories, anticoagulants, in the fifteen days before the procedure. * Vitamin D supplementation, with normal serum levels and which you do not agree to suspend; * Use of anabolic hormones; * Vitamin D (25 hydroxyvitamin D) greater than 70 ng/mL; * Serum calcium greater than 10 mg/dL; * Patients with total body PMMA volume of 650mL or more.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by clinical evaluation | Before application of PMMA and 6 and 9 months after the procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in normal values of laboratory biochemical tests | Before application of PMMA and 6 and 9 months after the procedure | laboratory biochemical exams |
| Volumetric capacity of filled muscle assessed by ultrasound imaging | Before application of PMMA and 6 and 9 months after the procedure | Using an ultrasound device, images of the gluteus will be obtained to analyze the thickness of the muscle, and thus estimate its volumetric capacity. |
| Physician satisfaction assessed by GAIS scale | Before application of PMMA and 4, 6 and 9 months after the procedure | 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. |
| Patient satisfaction assessed by GAIS scale | Up to 4, 6 and 9 months after the procedure | 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. |
Contacts
Primary ContactCarlos P Cunha
Outcome results
None listed