Interventional, Multicenter, Single-Arm Clinical Trial of Buttock Augmentation With Polymethylmethacrylate
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 133
- 主要终点
- Number of participants with treatment-related adverse events as assessed by clinical evaluation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by clinical evaluation
时间窗: 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.
次要结局
- 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)