Safety and Efficacy of Noninvasive Repetitive Pulse Magnetic Stimulation (rPMS) for Fat Disruption of the Abdomen
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 4
- 主要终点
- Effectiveness of the device assessed through photography evaluation
研究概览
简要总结
The study is a prospective multi-center open-label single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and four follow-up visits, 1 month, 3, 6 and 12 months after the final treatment.
At the baseline visit photographs of the abdomen will be taken. In addition, patient umbilical circumference will be measured and the subject's weight will be recorded. In addition, at the last therapy visit, subjects will receive Subject Satisfaction and Therapy Comfort Questionnaires to fill in.
Safety measures will include documentation of adverse events (AE) including subject's experience of pain or discomfort after the procedure. Following each treatment administration and at the follow-up visits, subjects will be checked for immediate post-procedure adverse event assessment.
Post-procedure evaluation (follow-up visits) will be conducted 1 month, 3, 6 and 12 months after the final treatment. Umbilical circumference and weight measure will be conducted at every follow-up visit. Also, subject's satisfaction will be noted. During the first (1 month), third (6 months) and last (12 months) follow-up visits, photographs of abdomen will be taken.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult subjects of both genders with unwanted abdominal fat and expressing interest in treatment
- •Age ≥ 22 years
- •Voluntarily signed informed consent form
- •BMI ≤ 30 kg/m2
排除标准
- •Cardiac pacemakers
- •Electronic implants
- •Pulmonary insufficiency
- •Metal implants
- •Drug pumps
- •Haemorrhagic conditions
- •Anticoagulation therapy
- •Heart disorders
- •Malignant tumor
- •Pregnancy
- •Breastfeeding
- •Following recent surgical procedures when muscle contraction may disrupt the healing process
- •Application over menstruating uterus
- •Application over areas of the skin which lack normal sensation
- •Scars, open lesions and wounds at the treatment area
- •Unrepaired abdominal hernia
结局指标
主要结局
Effectiveness of the device assessed through photography evaluation
时间窗: 13 months
Photography evaluations with correct identification of pre-treatment images compared to post-treatment images.
Effectiveness of the device assessed through change in adipose/muscle layer thickness
时间窗: 13 months
Change in umbilical circumference between pre-treatment and post-treatment based on waist circumference measure.
Subject's satisfaction
时间窗: 13 months
The 5-point Likert scale Subject Satisfaction Questionnaire will be used for an analysis of the subject's opinion of the therapy results. Subjects will be evaluating agreement with three different statements (concerning satisfaction with therapy results and appearance of abdominal area after therapy) by choosing an answer on a scale between 1 (Strongly disagree) and 5 (Strongly agree). Minimally 80% of the treated subjects should report the agreement with all three statements given in the questionnaire (answers "Agree" and "Strongly agree") in order to claim subject's satisfaction with the therapy outcome.
次要结局
- Therapy comfort(3 months)
- Safety of the device for non-invasive fat disruption(13 months)