NCT01823653已完成不适用
A Study to Investigate the Safety and Efficacy of Treatment of Subcutaneous Adipose Tissue in the Thighs Using the Liposonix System (Model 2)
Solta Medical7 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2012年7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
- 60
- 试验地点
- 7
- 主要终点
- Clinical Improvement in Thigh Circumference
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of treatment with the Liposonix System (Model 2) for the circumferential reduction of subcutaneous adipose tissue (SAT) of the thighs.
详细描述
Subjects received a single treatment (Liposonix System) on one randomly assigned thigh. The opposite thigh was not treated and served as a control for each subject.
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
- •Male or female subjects between 18-60 years of age
- •Body Mass Index of ≤30 lb/in2
- •Thickness of adipose tissue is at least 1.0 cm beyond the selected focal depth in the area to be treated (≥2.3cm)
- •Subjects must agree not to alter their regular diet or exercise routines during the course of the study
- •Subjects must be willing and able to comply with all study visit requirements, procedures, and assessments
- •Subject must understand the nature of the study and sign an IRB approved Informed Consent
排除标准
- •Subjects is pregnant
- •Subjects diagnosed with a coagulation disorder or receiving anticoagulant therapy
- •Subject has had prior aesthetic procedures in the area to be treated
- •Subjects has pacemaker, defibrillator, or other implantable electrical device
- •Subject has significant circumferential asymmetry between thighs
结局指标
主要结局
Clinical Improvement in Thigh Circumference
时间窗: 12 weeks (minus baseline)
Clinical improvement measured by change from baseline thigh circumference after treatment
次要结局
- Safety Assessment(1, 4, 8, 12 weeks)
- Percentage of Participants Showing Clinical Improvement Using the Global Aesthetic Improvement Scale (GAIS) Post Treatment, Assessed by Investigator(12 weeks)
- Patient Satisfaction Using 1-5 Likert Scale(12 weeks)
- Subcutaneous Adipose Thickness(12 weeks)
- Global Aesthetic Improvement Scale (GAIS) Score Post Treatment Assessed by Investigator for Determining Clinical Improvement(12 weeks)
研究者
研究点 (7)
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