NCT01853397已完成不适用
An Evaluation of the Safety and Effectiveness of Treatment of Adipose Tissue With the Liposonix System (Model 2) Using a New Treatment Method
Solta Medical4 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2013年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 4
- 主要终点
- Change in Waist Circumference 12 Weeks After Treatment as Compared to Baseline
研究概览
简要总结
The purpose of this study is to evaluate the safety, efficacy, and tolerability of treatment with the Liposonix System (Model 2)using a single pass technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Male or female, 18 to 65 years of age
- •Body Mass Index of ≤30 kg/m2
- •Thickness of subcutaneous adipose tissue in the anticipated treatment area of ≥ 2.3 cm
- •Subjects must agree to not alter their normal and regular diet or exercise routines during the course of the study
- •Subject must understand the nature of the study and sign an IRB approved Informed Consent
排除标准
- •Subject is pregnant
- •Subject is diagnosed with coagulation disorders or are receiving anticoagulant therapy or medications or dietary supplements which impede coagulation or platelet aggregation
- •Subject has diabetes or cardiovascular disease
- •Subject has had prior aesthetic procedures to the region to be treated
- •Subject has had previous open or laparoscopic surgery in the anticipated treatment area
- •Subject is on prescription or over the counter weight reduction medication or programs, or had weight reduction procedures
- •Subjects undergoing chronic steroid or immunosuppressive therapy
- •Subject has cardiac pacemakers or any implantable electrical device
- •Subject has a History of cancer
- •Subject has sensory loss or dysesthesia in the area to be treated
- •Subjects who are unable, or lack the capacity, to self consent
结局指标
主要结局
Change in Waist Circumference 12 Weeks After Treatment as Compared to Baseline
时间窗: 12 weeks
Change from baseline in waist circumference 12 weeks after treatment was assessed by blinded evaluators.
次要结局
- Change in Waist Circumference 4,8, and16 Weeks After Treatment as Compared to Baseline(4 weeks, 8 weeks, 16 weeks)
- Investigator Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS)(4, 8, 12, and 16 weeks)
- Subject Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS)(4, 8, 12, and 16 weeks)
- Subject Satisfaction With Treatment(4, 8, 12, and 16 weeks)
研究者
研究点 (4)
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