NCT01104272已完成不适用
An Evaluation of the Treatment of Adipose Tissue Using a Focused Ultrasound Device in Subjects With Fitzpatrick IV-VI Skin Types
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- Change from baseline in waist circumference
研究概览
简要总结
The device delivers High Intensity Focused Ultrasound (HIFU) energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to body sculpting, such as a reduction in waist circumference.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- 否
入选标准
- •All of the following inclusion criteria must be met at the time of screening before the subject is enrolled into the study:
- •Male or female subjects, 18 to 65 years of age
- •Body Mass Index ≤30
- •Thickness of subcutaneous adipose tissue in the anticipated treatment area of ≥ 2.5 cm
- •Subjects must agree to not alter their normal and regular diet or exercise routines during the course of the study.
- •Subjects must be of African descent AND have Fitzpatrick skin types IV, V, or VI.
排除标准
- •A subject is ineligible to participate in this study if they meet any of the following exclusion criteria at screening:
- •Female subject who is pregnant (i.e., has a positive urine pregnancy test), is suspected to be pregnant, or is lactating or becomes pregnant during the course of the study. (NOTE: Females of childbearing potential must have a negative urine pregnancy test prior to enrollment in the study.)
- •Subjects 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 any aesthetic procedure to the region to be treated.
- •Subject has systemic skin disease or skin disease in the areas to be treated.
- •Subject has any abnormality of the skin or soft tissues of the abdominal wall in the areas to be treated.
- •Subject has had previous open or laparoscopic surgery in the anticipated treatment area.
- •Subjects is on prescription or over the counter weight reduction medication or programs, or had weight reduction procedures (e.g.: gastric bypass, Lap-Band, etc.)
- •Subject has skin or superficial tissue that does not lie flat on its own when the subject is in the supine position.
- •Subjects undergoing chronic steroid or immunosuppressive therapy.
- •Subjects who have cardiac pacemakers or any implantable electrical device, e.g. pacemaker, defibrillator, or neurostimulators.
- •Subjects who have metal implants of any type in the area to be treated.
- •History of cancer.
- •Subjects who have sensory loss or dysesthesia in the area to be treated.
- •Subject currently uses illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than 4 alcoholic drinks per day).
- •Subjects who cannot adhere to the study visit schedule (e.g., subjects not likely to stay in the study for a maximum of 27 weeks - screening through exit visit).
- •Subjects who are unable, or lack the capacity, to self consent.
结局指标
主要结局
Change from baseline in waist circumference
时间窗: 12 weeks
次要结局
- The change from Baseline in waist circumference measured after treatment, for the average of the two waist circumference measurements at the iliac crest as well as for each of the individual measurements.(8 weeks)
- Patient satisfaction as recorded on the Subject Satisfaction Survey after treatment.(12 weeks)
- Visual Analog Scale (VAS) diary to record post treatment discomfort.(1 week)
- Improvement as determined by a Global Aesthetic Improvement Scale (GAIS) score of 'improved' or 'much improved' at each post-baseline visit, as assessed by the Investigator.(12 weeks)
研究者
研究点 (4)
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