NCT03545360Unknown不适用
Safety and Efficacy of the BTL-703 Treatment for the Non-invasive Lipolysis
BTL Industries Ltd.1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2018年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Waist circumference reduction
研究概览
简要总结
The study will evaluate safety and efficacy of the BTL-703 device for the non-invasive lipolysis.
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
- •Age ≥ 22 years
- •Voluntarily signed informed consent form
排除标准
- •Implanted electronic device such as a cardiac pacemaker, bladder stimulator, spinal cord stimulator or electrodes for a myoelectric prosthesis, etc.
- •Diabetics dependent on insulin or oral hypoglycemic medications
- •Known cardiovascular disease such as arrhythmias, congestive heart failure
- •Cardiac surgeries such as cardiac bypass, heart transplant surgery, pacemakers.
- •Prior surgical interventions for body sculpting of thighs or buttocks such as liposuction
- •Medical, physical or other contraindications for body sculpting/ weight loss
- •Current use of medication known to affect weight levels and/or cause bloating or swelling and for which abstinence during the course of study participation is not safe or medically prudent
- •Any medical condition known to affect weight levels and/or to cause bloating or swelling
- •Active infection, wound or other external trauma to the area to be treated
- •Pregnant, breast feeding, or planning pregnant before the end of the study
- •Serious mental health illness
- •Active or recurrent cancer or current chemotherapy and/or radiation treatment
- •Negative affection to heat
研究组 & 干预措施
Treatment Group
Experimental
Treated group of subjects, serves as its own control
干预措施: BTL-703 (Treatment group) (Device)
结局指标
主要结局
Waist circumference reduction
时间窗: 5 months
The waist circumference measure will be conducted in accordance to the WHO STEPwise approach to surveillance (2008.) and NHLBI Obesity Education Initiative (2000.) recommendations. The waist circumference after the therapy will be compared to baseline.
次要结局
- Serious adverse events following the treatment(5 months)
- Photo evaluation(5 months)
- Subject Satisfaction(5 months)
- Therapy discomfort(2 months)
研究者
研究点 (1)
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