Effect on BTL-899 Device for Non-invasive Lipolysis on Human Thighs and Saddlebags
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Participants' Satisfaction Measured Via Questionnaires
研究概览
简要总结
The study is a prospective two-arm, open-label, interventional study with four treatment procedures and two follow-up visits.
详细描述
This study aims to evaluate the clinical safety and efficacy of the BTL-899 device for non-invasive lipolysis and fat reduction in the thigh and saddlebag area. This is a prospective, open-label, two-arm study; therefore the participants will be assigned to two study groups. Each participant will complete 4 treatment visits and 2 follow-up visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) of 20 to 35 kg/m
- •Visible excess of adipose tissue at the treatment sites (ARM 1 - thigh area; ARM 2 - saddlebags area).
- •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.
- •No procedure for fat reduction (including cellulite treatment) in the last six months.
- •Subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without effecting a significant change of weight in either direction during study participation.
- •Age between 21 and 70 years.
排除标准
- •Electronic implants (such as intrauterine device, cardiac pacemakers, defibrillators, and neurostimulators)
- •Cardiovascular diseases
- •Vascular diseases (such as chronic venous insufficiency, deep venous thrombosis, varicose veins, etc.)
- •Femoral or inguinal hernia
- •Disturbance of temperature or pain perception
- •Pulmonary insufficiency
- •Metal implants
- •Drug pumps
- •Malignant tumor
- •Hemorrhagic conditions
- •Septic conditions and empyema
- •Acute inflammations
- •Systemic or local infection such as osteomyelitis and tuberculosis
- •Contagious skin disease
- •Elevated body temperature
- •Pregnancy
- •Breastfeeding
- •Injured or otherwise impaired muscles
- •Scars, open lesions, and wounds at the treatment area
- •Basedow's disease
- •Previous liposuction in the treatment area in the last six months
- •Unstable weight within the last 6 months (change in weight ± 3%)
- •Previous body contouring or cellulite treatments in the thighs area in the last six months
- •Any other disease or condition at the investigator's discretion
结局指标
主要结局
Participants' Satisfaction Measured Via Questionnaires
时间窗: 6 months
Evaluation of the participants' satisfaction with the therapy via Therapy Satisfaction Questionnaires. Global Aesthetic Improvement Scale (Quality of Life questionnaire) will be used where score "3" means "very much improved" and "-3" is "very much worse".
Changes in Fat Thickness Measured via Ultrasound
时间窗: 6 months
To gather clinical evidence that the BTL-899 device is able to induce non-invasive lipolysis when used on thighs and saddlebags. The fat thickness changes will be measured by means of ultrasound.
Evaluation of the Therapy's Safety Measured Via Therapy Comfort Questionnaire
时间窗: 6 months
The outcome will further be measured through the occurrence of adverse events or lack thereof. On Numerical Analog Scale (0-10), where 0 represents 'no pain' and 10 represents 'worst possible pain' select the level of pain experienced during the treatment.
次要结局
未报告次要终点