NCT03758690已完成不适用
Efficacy of Abdominal Treatment With High-Intensity Focused Electromagnetic (HIFEM) Field Device in Women After Childbirth
BTL Industries Ltd.4 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年10月25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
- 10
- 试验地点
- 4
- 主要终点
- Effectiveness of the device for abdominal toning according to MRI images
研究概览
简要总结
Evaluation of use of the High-Intensity Focused Electromagnetic (HIFEM) Field Device in women after childbirth.
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
- Female
- 接受健康志愿者
- 是
入选标准
- •Non-breastfeeding women 3-36 months after childbirth
- •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
- •Pregnancy
- •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
Effectiveness of the device for abdominal toning according to MRI images
时间窗: 7 months
Evaluation of MRI images before and after the therapy procedure.
Effectiveness of the device for abdominal toning according to waist circumference measurements
时间窗: 7 months
Evaluation of waist circumference measurements (in centimeters).
次要结局
- Subject's satisfaction with study treatment: Questionnaire(7 months)
- Determination of side effects and adverse events (AE) associated with the study device.(7 months)
研究者
研究点 (4)
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