Abdominal Treatment With Simultaneous Application of Noninvasive Repetitive Pulse Magnetic Stimulation (rPMS) and Radiofrequency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 4
- 主要终点
- Evaluation of change in adipose layer thickness between pre-treatment and post-treatment based on waist circumference measurements
研究概览
简要总结
This study will evaluate the clinical efficacy and safety of a simultaneous treatment by repetitive pulse magnetic stimulation and radiofrequency energy for toning of abdomen and reduction of subcutaneous fat. 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 three (3) treatment visits and two to three follow-up visits. All of the study subjects will receive the treatment with the subject device.
详细描述
This study will evaluate the clinical efficacy and safety of a simultaneous treatment by repetitive pulse magnetic stimulation and radiofrequency energy for toning of abdomen and reduction of subcutaneous fat. 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 three (3) treatment visits and two to three follow-up visits. All of the study subjects will receive the treatment with the subject device.
At the baseline visit MRI will be performed, subject's weight and waist circumference will be recorded. Photos of the treated area will be taken.
The treatment administration phase will consist of three (3) treatments, delivered once a week. The applicator will be applied over umbilicus and visible muscle contractions along with heating of the subcutaneous fat will be induced by the device.
At the last therapy visit, the subject's weight and waist circumference will be recorded, and photos of the treated area will be taken. In addition, subjects will receive Subject Satisfaction Questionnaire to fill in.
Safety measures will include documentation of adverse events (AE) including subject's experience of pain or discomfort after each procedure. Following each treatment administration and at all of the follow-up visits, subjects will be checked for immediate post-procedure adverse event assessment.
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 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 tumour
- •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 change in adipose layer thickness between pre-treatment and post-treatment based on waist circumference measurements
时间窗: 4 months
Waist circumference measure will be conducted at the baseline visit, after last treatment and during follow-up visits. The waist circumference measure will be made at the top of the subject's iliac crest, with the tape held snugly, but not constricting, and at a level parallel to the floor. For the measurement, a stretch-resistant tape will be used. During the measuring, subject will stand with arms at the side, feet positioned close together, and weight evenly distributed across the feet. The subject will be instructed to relax and take a few deep, natural breaths before the actual measurement is made. The subjects will be measured in underwear only, after voiding the bladder.
Evaluation of change in adipose and muscular layer thickness between pre-treatment and post-treatment based on MRI scans
时间窗: 4 months
MRI will be conducted at the baseline visit and all follow-up visits. The imaging will be conducted at the same surface area each time. Hospital-grade MRI device will be used to scan abdominal area of each subject. The MRI scan without any contrast agent will be performed, with the scanned body segment determined by vertebrae T12 and S1. Lateral cuts from 5 cm below the umbilicus and 5 cm above the umbilicus will be evaluated for the thickness of muscle and subcutaneous adipose tissue.
次要结局
- Safety of the device measured via the occurrence of adverse events or lack thereof(7 months)
- Evaluation of subject's satisfaction with the treatment using the Subject Satisfaction Questionnaire(7 months)