Buttock Augmentation With Polymethylmethacrylate
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PMMA.
- Who it may be relevant to
- Registry conditions: Aesthetics, Augmentation. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Interventional, Multicenter, Single-Arm Clinical Trial of Buttock Augmentation With Polymethylmethacrylate
Overview
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
- Device PMMA
PMMA 30%
Primary outcome measures
- 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]
Secondary outcome measures (4)
- Changes in normal values of laboratory biochemical tests [Time frame: Before application of PMMA and 6 and 9 months after the procedure]
- Volumetric capacity of filled muscle assessed by ultrasound imaging [Time frame: Before application of PMMA and 6 and 9 months after the procedure]
- Physician satisfaction assessed by GAIS scale [Time frame: Before application of PMMA and 4, 6 and 9 months after the procedure]
- Patient satisfaction assessed by GAIS scale [Time frame: Up to 4, 6 and 9 months after the procedure]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Nicareta B, Pereira LH, Sterodimas A, Illouz YG. Autologous gluteal lipograft. Aesthetic Plast Surg. 2011 Apr;35(2):216-24. doi: 10.1007/s00266-010-9590-y. Epub 2010 Sep 25. PMID 20871994
- Talbot SG, Parrett BM, Yaremchuk MJ. Sepsis after autologous fat grafting. Plast Reconstr Surg. 2010 Oct;126(4):162e-164e. doi: 10.1097/PRS.0b013e3181ea4541. PMID 20885205
- Stojicic M, Jurisic M, Marinkovic M, Jovanovic M, Igic A, Nikolic Zivanovic M. Necrotizing Skin and Soft Tissue Infection after Gluteal Augmentation in a Perioperatively Asymptomatic COVID-19 Patient-Complications of the Post-Lockdown Era? A Case Report. Medicina (Kaunas). 2023 May 10;59(5):914. doi: 10.3390/medicina59050914. PMID 37241146
- Guzey S, Ergan Sahin A. Brazilian Butt Lift: An Experience Over 3000 Patients. Aesthetic Plast Surg. 2024 Jul;48(14):2677-2693. doi: 10.1007/s00266-024-03965-8. Epub 2024 Apr 5. PMID 38580866
Identifiers
NCT: NCT06544304 · MTC_01_2024_V1