Cutera Radio Frequency Device for Thigh Circumference Reduction
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Difference in Circumference of Upper Thigh Between Treated and Untreated Control Arms
研究概览
简要总结
The purpose of this study is to evaluate the Cutera radio frequency (RF) device for the new indication of reduction of thigh circumference.
详细描述
The purpose of this study is to evaluate the Cutera radio frequency device for the new indication of reduction of thigh circumference.
At investigator's discretion, each subject will receive up to three treatments on one thigh and will be scheduled for two follow-up visits after the final treatment. The treated thigh will be clinically evaluated for side effects and both treated and untreated control thigh will be measured and photographed at each visit for analysis. Subjects will also be weighted at each visit and asked to fill out a survey during follow-up visits.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Body Mass Index between 20 and 35
- •Presence of cellulite grades II, III or IV according to GLD scale
- •Visible bi-lateral thigh fat Thigh area to be treated to measure at least 30.0mm in vertical fold, as measured with industry standard fat caliper
- •Subject must be able to read, understand and sign the Consent Form
- •Subject must adhere to the follow-up schedule and study instructions
- •Subject must adhere to the same diet and/or exercise routine throughout the study
排除标准
- •Significant weight fluctuation (+/-10 lbs) in the past 6 months
- •Taking weight-loss medications/supplements
- •Participation in any other clinical study
- •Cellulite treatment within 3 months of the treatment
- •Surgical or non-surgical treatments to the target area in the last 12 months, e.g., liposuction
- •Prior treatment to the target area within the last 12 months
- •Arteriosclerosis or weakened blood vessels
- •Heart disease
- •Thromboembolic disease
- •Diagnosed or documented immune system disorders
- •Bleeding disorders.
- •Presence of uncontrolled hypertension
- •Taking prescription anticoagulants
- •History of keloid formation
- •Malignant tumors in the target area
- •Any disease or condition that could impair wound healing
- •Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars
- •Infection in the target area
- •Implanted electrical device(s)
- •Pregnant or lactating
结局指标
主要结局
Difference in Circumference of Upper Thigh Between Treated and Untreated Control Arms
时间窗: Baseline and 6 months post final treatment
Mean difference of change from baseline between two arms: \[Treated arm - Untreated arm\]
Difference in Circumference of Mid Thigh Between Treated and Untreated Control Arms
时间窗: Baseline and 6 months post final treatment
Mean difference of change from baseline between two arms: \[Treated arm - Untreated arm\]
次要结局
- Subject Satisfaction(Baseline and 6 months post final treatment)
- Adverse Events(At each visit (treatment and follow-up) or until resolution of AEs)