Baseline Controlled Two-arm Multi-Center Study to Evaluate the Safety and Efficacy of Combined Multi-Focus Treatments of UltraShape® Contour I V3 System and VelaShape II Device for Non-Invasive Circumference Reduction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 4
- 主要终点
- Difference in circumference reduction between baseline and follow-up visits
研究概览
简要总结
The purpose of this study is to compare the clinical performance of the Ultrashape system with VelaShape II device for reduction of the waist.
详细描述
UltraShape® Contour I V3 system is a non-invasive (not breaking the skin) focused ultrasound for body contouring purposesdesigned to selectively disrupt sub-dermal fat cells employing focused ultrasound. All other types of tissue, such as blood vessels, muscles and peripheral nerves, remain intact. There are no thermal effects. Fat-cell destruction is achieved by ultrasound-induced mechanical effects during a very short exposure time.
VelaShape is a non-invasive device for Body Reshaping and Cellulite Treatment. VelaShape combines controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with mechanical manipulation.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fat thickness of at least 1.5 cm in the anterior abdominal and flanks prior to initial treatment (measurement by caliper)
- •For women of child-bearing potential: negative pregnancy test in the 24 hour period prior to enrollment and 24 hour period prior to each treatment or FU visit (measured in urine)
- •General good health confirmed by medical history and skin examination of the treated area
- •Written informed consent to participate in the study
- •Ability to comply with the requirements of the study
排除标准
- •History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator, abdominal aortic aneurism
- •Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease or malignancy
- •Previous liposuction in the treatment areas
- •History of skin disease in the treatment area, known tendency to form keloids or poor wound healing
- •Skin lesions in the treatment area other than simple nevi on physical examination (e.g., atypical nevus, tattoo, abrasions) including depressed scars in the treatment area
- •Poor skin quality (i.e., laxity)
- •Abdominal wall diastasis or hernia on physical examination
- •Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months
- •Obesity (BMI > 30)
- •Childbirth within the last 12 months or women who suckling a child
- •Any acute or chronic condition which, in the opinion of the Investigator, could interfere with the conduct of the study
- •Unstable weight within the last 6 months (i.e., ± 3% weight change in the prior six months)
- •Inability to comply with circumference measurement procedure (e.g., inability to held breath for the required duration)
- •Participation in another clinical study
- •Previous body contouring treatments in the treatment areas
结局指标
主要结局
Difference in circumference reduction between baseline and follow-up visits
时间窗: Base line, 2 and 12 weeks post last treatment
The primary efficacy endpoint in this trial is the statistical difference in circumference reduction between Control (baseline measurement, Vist 2 / Day 0) and two points of follow-up measurement: 2 weeks (Visit 5 / Day 42) and 12 weeks (Visit 8 / Day 112) following the last Tx session. The following procedure will be used to compute the Circumference Difference primary endpoint:
次要结局
- Adverse Events(The duration of the study, an expected average of 5 months.)