Evaluation of Safety and Efficacy of the BTL-899 Device for Non-invasive Lipolysis and Circumference Reduction of Abdomen
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Efficacy of the BTL-899 treatment for abdomen circumference reduction after the final follow-up visit
研究概览
简要总结
The study is a prospective open-label single-arm study that includes three treatment procedures and four follow-up visits.
详细描述
This study will evaluate the clinical efficacy and safety of the BTL-899 device for non-invasive lipolysis and circumference reduction of abdomen. The study is a prospective open-label single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will complete three (3) treatment visits and will be invited to four (4) follow-up visits 1, 2, 3 and 6-months after the final treatment. 6-months follow-up visit is the optional one.
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 ≥ 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 his/her regular (pre-procedure) diet and exercise regimen without effecting significant change in either direction during study participation
排除标准
- •Cardiac pacemakers
- •Cardiovascular diseases
- •Implanted defibrillators, implanted neurostimulators
- •Electronic implants
- •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
- •Contageous 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
- •Abdominal wall diastasis
- •Unstable weight within the last 6 months
- •Previous body contouring treatments in the abdomen area in the last three months
结局指标
主要结局
Efficacy of the BTL-899 treatment for abdomen circumference reduction after the final follow-up visit
时间窗: 4 months
Evaluation of change in abdomen circumference using tape measurements in cm at the final follow-up visit.
Occurrence of adverse events
时间窗: 7 months
The occurrence of adverse events will be followed throughout the whole study.
次要结局
- Efficacy of the BTL-899 treatment for abdomen circumference reduction(4 months)
- Therapy comfort during the study treatment.(1 month)
- Efficacy of BTL-899 treatment for fat and circumference reduction in abdomen, as assessed by two blinded evaluators(4 months)
- Subject's satisfaction with study treatment(4 months)
- Ultrasound imaging(4 months)