Simultaneous Application of High-Intensity Focused Electromagnetic Procedure and Radiofrequency for Toning of Buttocks
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 9
- 主要终点
- The evaluation of change in adipose and muscle layer thickness.
研究概览
简要总结
This study will evaluate the clinical efficacy and safety of the BTL-899 device for toning of buttocks. The study is a prospective multi-center open-label two-arm study. The subjects will be enrolled and assigned into two study groups. The subjects will be enrolled and assigned into two study groups; HIFEM+RF (HR) and HIFEM (H) group. Subjects of both groups will be required to complete four (4) treatment visits and two follow-up visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 21 years
- •Voluntarily signed an informed consent form
- •BMI ≤ 35 kg/m2
- •Women of child-bearing potential are required to use birth control measures during the whole duration of the study
- •Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring during study participation
- •Subjects willing and able to maintain her regular (pre-procedure) diet and exercise regimen without affecting significant change in either direction during study participation
排除标准
- •Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)
- •Metal implants
- •Drug pumps
- •Malignant tumor
- •Pulmonary insufficiency
- •Injured or otherwise impaired muscles
- •Cardiovascular diseases
- •Disturbance of temperature or pain perception
- •Hemorrhagic conditions
- •Septic conditions and empyema
- •Acute inflammations
- •Systemic or local infection such as osteomyelitis and tuberculosis
- •Contagious skin disease
- •Elevated body temperature
- •Pregnancy, postpartum period, nursing, and menstruation
- •Intrauterine device (IUD)
- •Swollen or neoplastic tissues, space-occupying lesions or skin eruptions in the treatment area
- •Basedow's disease
结局指标
主要结局
The evaluation of change in adipose and muscle layer thickness.
时间窗: 4 months
The evaluation of change in adipose and muscle layer thickness between pre-treatment and post-treatment based on hip circumference measurements.
The evaluation of change in structure of subcutaneous tissues between pre-treatment and post-treatment based on MRI imaging in both study groups.
时间窗: 4 months
The evaluation of structural changes of subcutaneous tissues between pre-treatment and post-treatment based on MRI imaging through measurements of the thickness of subcutaneous tissues
次要结局
- Patient's satisfaction with study treatment measured via questionnaires(4 months)
- Evaluation of the Therapy's Safety Measured Via Therapy Comfort Questionnaire(4 months)