NCT02956720Unknown不适用
Clinical Evaluation of UltraShape Power System in Conjunction With the U-Sculpt-N Transducer for Non-invasive Circumference Reduction
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Outer thigh circumference reduction
研究概览
简要总结
Prospective, open label, self - controlled, single arm, clinical study to assess the performance of the UltraShape Power using the U-Sculpt-N on outer thigh and/or flank for circumference reduction versus self-control.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject ≥18 and ≤60 years of age at the time of enrollment
- •Fat thickness of at least 1.5 cm in the outer thigh and/or flank (measured by calibrated caliper)
- •For women of child-bearing potential: negative urine pregnancy test
- •General good health confirmed by medical history and skin examination of the treated area
- •Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.
排除标准
- •History of un-balanced hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator
- •Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease
- •Having a permanent implant in the treated area, such as metal plates, or an injected chemical substance such as silicone
- •Previous liposuction in the treatment areas within 12 months
- •History of skin disease in the treatment area, known tendency to form keloids or poor wound healing
- •Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months
- •Childbirth within the last 12 months or women who are breastfeeding a child
结局指标
主要结局
Outer thigh circumference reduction
时间窗: up to 24 week
To evaluate circumference reduction of outer thigh post treatment with UltraShape Power device used with the U-Sculpt-N transducer versus control side.
Treatment-related adverse events
时间窗: up to 24 week
The frequency and severity of all treatment-related adverse events during and after using the UltraShape Power device used with the U-Sculpt-N transducer.
次要结局
- Subject satisfaction questionnaire(up to 24 week)
研究者
Ronen Glesinger
Principal investigator
Syneron Candela
研究点 (1)
Loading locations...
相似试验
已完成
不适用
UltraShape Power for Abdominal Fat and Circumference ReductionExcess Abdominal FatNCT02748928Syneron Medical62
撤回
不适用
UltraShape Power Device for Fat Reduction in FlanksExcess Abdominal FatNCT03502473Syneron Medical
Unknown
不适用
Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Device for Non-Invasive Abdominal Fat ReductionExcess Abdominal FatNCT02700152Syneron Medical60
暂停
不适用
UltraShape Device Using the U-Sculpt/VDF Transducer for Flanks FatUnwanted Flanks FatNCT02465762Syneron Medical60
Unknown
不适用
Non-Invasive Abdominal Fat Reduction With BMI Above 28Unwanted FatNCT02711618Syneron Medical47