NCT03923855已完成不适用
Clinical Evaluation of the BTL-899 Device for Non-invasive Lipolysis on Human Fat Tissue
BTL Industries Ltd.1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2019年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Evaluation of Satefy: Occurence of adverse events throughout the study
研究概览
简要总结
The subjects will be enrolled and assigned to a single study group. They will be required to complete two treatment visits and come for a biopsy procedure.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age above 21 years and below 60 years
- •Voluntarily signing of the informed consent form
- •Women of child-bearing potential are required to use birth control measures during the whole duration of the study
- •Eligibility to fat tissue biopsy at surgeon discretion, incl. at least 3-4 cm pinchable fat in the abdominal area
- •Subjects willing and able to abstain from partaking in any 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
- •Electronic implants (such as cardiac pacemakers, defibrillators and neurostimulators)
- •Cardiovascular diseases
- •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
- •Abdominal wall diastasis
- •Unstable weight within the last 6 months (change in weight ± 3%)
- •Previous body contouring treatments in the abdomen area in the last three months
- •Any disease or condition contradicting the fat tissue biopsy at the surgeon discretion
- •Any disease or condition that may compromise the histologic observation at the pathologist discretion
研究组 & 干预措施
BTL-899 Therapy Arm
Experimental
干预措施: BTL-899 (Device)
结局指标
主要结局
Evaluation of Satefy: Occurence of adverse events throughout the study
时间窗: 4 months
Following the occurence of adverse events throughout the study.
Histology Examination
时间窗: 4 months
Histological examination of the fat tissue after BTL-899 treatment at various days after the procedure
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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