Efficacy of HIFEM Treatments for Strengthening and Toning of Arms, Lower Limbs and Oblique Muscles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 3
- 主要终点
- Changes in adipose and muscle tissue measured via ultrasound imaging
研究概览
简要总结
Evaluation of HIFEM treatments for strengthening and toning of arms, lower limbs and oblique muscles.
详细描述
This study will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of arm, lower limb and oblique muscles. The study is a prospective multi-center open-label four-arm study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Voluntarily signed informed consent form
- •BMI ≤ 30 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 effecting significant change in either direction during study participation
排除标准
- •Cardiac pacemakers
- •Implanted defibrillators, implanted neurostimulators
- •Electronic implants
- •Pulmonary insufficiency
- •Metal implants
- •Drug pumps
- •Application in the head area
- •Application in the heart area
- •Malignant tumor
- •Injured or otherwise impaired muscles
- •Pregnancy
- •Sensitivity or allergy to latex
- •Breastfeeding
- •Following recent surgical procedures when muscle contraction may disrupt the healing process
- •Application over areas of the skin which lack normal sensation
- •Scars, open lesions and wounds at the treatment area
- •Unrepaired abdominal hernia
- •Patients after Cesarean section delivery
结局指标
主要结局
Changes in adipose and muscle tissue measured via ultrasound imaging
时间窗: 7 months
To determine the effectiveness of the device for strengthening and toning of arms, lower limbs and oblique muscles through changes in surrounding tissues, measured via ultrasound imaging. Using the obtained images, change in adipose and muscular tissues before and after the therapy sessions will be compared for every participant according to the study phase.
次要结局
- Patient's satisfaction measured via questionnaires(7 months)
- Incidence Of Treatment-Related Adverse Events(7 months)