Interventional, Multicenter, Single-Arm Clinical Trial of Buttock Augmentation With Polymethylmethacrylate
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Enrollment
- 133
- Primary Endpoint
- Number of participants with treatment-related adverse events as assessed by clinical evaluation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Number of participants with treatment-related adverse events as assessed by clinical evaluation
Time Frame: 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 Outcomes
- Patient satisfaction assessed by GAIS scale(Up to 4, 6 and 9 months after the procedure)
- Changes in normal values of laboratory biochemical tests(Before application of PMMA and 6 and 9 months after the procedure)
- Volumetric capacity of filled muscle assessed by ultrasound imaging(Before application of PMMA and 6 and 9 months after the procedure)
- Physician satisfaction assessed by GAIS scale(Before application of PMMA and 4, 6 and 9 months after the procedure)