NCT01609699Unknown不适用
A Baseline Controlled Study to Evaluate the Effectiveness of the UltraShape® Contour I - Y System for Non-Invasive Reduction in Abdominal Circumference
UltraShape2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The primary objective of this study is to evaluate the efficacy of the Contour I - Y System on abdominal circumference reduction relative to baseline pretreatment values using different treatment methods.
研究概览
简要总结
The UltraShape® Contour I- Y system uses focused ultrasound to produce localized mechanical motion within fat tissues and cells for the purpose of producing mechanical cellular membrane disruption. It is intended for reduction in body circumference.
The primary objective of this study is to evaluate the efficacy of the Contour I - Y System on abdominal circumference reduction relative to baseline pretreatment values using different treatment methods.
The primary efficacy endpoint in this trial is Statistical Difference of Circumference reduction between Baseline measurement and at follow-up measurement.
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
- None
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
- •Female or male subjects, 18-65 years of age at the time of enrollment
- •Abdominal and flank fat thickness of at least 1.5 cm prior to initial treatment (measurement by caliper)
- •For women of child-bearing potential: negative pregnancy test in the 24 hour period prior to enrollment (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 abdomen or love handle areas
结局指标
主要结局
The primary objective of this study is to evaluate the efficacy of the Contour I - Y System on abdominal circumference reduction relative to baseline pretreatment values using different treatment methods.
时间窗: 3.5 months
次要结局
- The secondary objective of this study subject satisfaction measured with a self-assessment questionnaire(3.5 months)
- Rate of device and procedure related adverse event adverse(3.5 months)
研究者
研究点 (2)
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