Effect of BTL-899 Device for Non-invasive Lipolysis on Human Upper Arms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Statistically significant reduction of fat thickness in the upper arms evaluated by photographs
研究概览
简要总结
This study will evaluate the clinical safety and the performance of the BTL-899 device during the treatment of upper arms.
详细描述
The aim of the study is to confirm the efficacy and the safety of the treatment. The efficacy (reduction of excess adipose tissue) will be assessed via correct identification of pre-treatment and 3-months follow-up images by at least two out of three independent blinded evaluators. The fat reduction will be also measured by means of ultrasound. Comfort and satisfaction will be assessed via standard questionnaires.
Safety measures will include documentation of adverse events (AE) during and after the procedures.
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 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 site
- •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 in the area 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 the study participation.
排除标准
- •Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)
- •Cardiovascular diseases
- •Vascular diseases (such as chronic venous insufficiency, deep venous thrombosis, varicose veins, etc.)
- •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 in the arms
- •Scars, open lesions, and wounds at the treatment area
- •Basedow's disease
- •Previous liposuction in the treatment area in the last six months
- •Any other disease or condition at the investigator's discretion, e.g. dislocated shoulder or carpal tunnel syndrome than can pose danger to the patient or compromise the study
结局指标
主要结局
Statistically significant reduction of fat thickness in the upper arms evaluated by photographs
时间窗: 5 months
To gather clinical evidence that the BTL-899 device is able to induce non-invasive lipolysis when used on upper arms. The primary efficacy outcome measure is a minimum 75% of the subjects' pre-treatment and 3-months follow-up images to be correctly identified by at least two of three independent blinded evaluators.
次要结局
- Evaluation of the Therapy's Safety Measured Via Therapy Comfort Questionnaire(7 months)
- Evaluation of the participants' satisfaction with the therapy evaluated via standard questionnaires(5 months)