NCT04599257已完成不适用
Simultaneous Application of High-Intensity Focused Electromagnetic Procedure and Radiofrequency for Changes in Subcutaneous Fat Tissue and Muscle Toning of Thighs
BTL Industries Ltd.8 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2020年9月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 试验地点
- 8
- 主要终点
- Evaluation of structural changes of subcutaneous tissues between pre-treatment and post-treatment based on MRI imaging
研究概览
简要总结
This study will evaluate the clinical efficacy and safety of a simultaneous application of high-intensity focused electromagnetic procedure and radiofrequency energy for changes in subcutaneous fat tissue and muscle toning of thighs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（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
Evaluation of structural changes of subcutaneous tissues between pre-treatment and post-treatment based on MRI imaging
时间窗: 7 months
The primary objective of the study is to determine the effectiveness of a simultaneous application of high-intensity focused electromagnetic procedure and radiofrequency energy for change in the adipose layer thickness between pre-treatment and post-treatment based on MRI imaging. The changes will be considered statistically significant where p-value \<0.05.
次要结局
- Assess safety profile by recording of adverse events(7 months)
- Assess subjects' satisfaction with the treatment using Subject Satisfaction Questionnaire(7 months)
研究者
研究点 (8)
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