Buttock Augmentation With Polymethylmethacrylate

MTC MEDICAL COMERCIO INDUSTRIA IMPORTACAO E EXPORTACAO DE PRODUTOS BIOMEDICOS LTDA

Status and phase

Not yet enrolling

Phase 3

Conditions

Augmentation

Aesthetics

Treatments

Device: PMMA

Study type

Interventional

Funder types

Other

Identifiers

NCT06544304

MTC_01_2024_V1

Details and patient eligibility

About

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.

Full 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.

Enrollment

133 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.