Evaluation of the Effectiveness of the BTL-9000 High Frequency Therapy for the Waist Circumferential Reduction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Waist Circumference Reduction
研究概览
简要总结
Prospective, two-arm, randomized study of the effectiveness of the BTL-9000 HFT in achieving 3 cm or greater average waist circumferential reduction in HFT group of subjects relative to the base line and 1 cm or greater reduction relative to the average waist circumferential reduction of the Placebo group.
详细描述
Prospective, randomized, blinded, two-arms study of waist circumferential reduction following 5 once-a-week treatments. One arm is the HFT group of 64 subjects who are treated with the BTL-9000 HFT and the other arm is the Placebo group of 38 subjects treated with the sham device. The objective of the study is to demonstrate the effectiveness of the BTL-9000 HFT treatment in achieving average post-treatment waist circumference reduction of 3 cm or greater across the waistline relative to the baseline assessment and of 1 cm or greater than the average waist circumferential reduction of the Placebo group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects 18-70 years of age of both gender with excess adipose tissue in the abdomen area
- •Body Mass Index (BMI) of 25 to 35 kg/m
- •Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring and/or weight loss during study participation.
- •Subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without effecting significant change in either direction during study participation.
排除标准
- •- 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.
- •Implanted electronic device such as a cardiac pacemaker, bladder stimulator, spinal cord stimulator or electrodes for a myoelectric prosthesis, etc.
- •Prior surgical interventions for body sculpting of abdomen 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
- •Negative affection to heat
- •Active or recurrent cancer or current chemotherapy and/or radiation treatment
结局指标
主要结局
Waist Circumference Reduction
时间窗: 1 month follow up after 5 once-a-week treatments
The subjects in the HFT group whose average post-treatment waist circumference shows reduction of 3 cm or greater across the waistline relative to the base line assessment and their mean waist circumferential reduction is 1 cm or greater than the average circumferential reduction of Placebo group are considered to meet the study primary outcome success criteria.
次要结局
- Adverse Events(1 month follow up)