Status:
NOT_YET_RECRUITING
Buttock Augmentation With Polymethylmethacrylate
Lead Sponsor:
MTC MEDICAL COMERCIO INDUSTRIA IMPORTACAO E EXPORTACAO DE PRODUTOS BIOMEDICOS LTDA
Conditions:
Aesthetics
Augmentation
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT06544304
Start Date
January 1 2025
End Date
August 1 2026
Last Update
August 9 2024
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