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
Qualifiers
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
Treatments tested in this trial
- PMMA
Treatment groups
133 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov