NCT01665118已完成不适用
The Cutera Trusculpt Device For Thigh Circumference Reduction
Cutera Inc.6 个研究点 分布在 1 个国家目标入组 44 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
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 6
- 主要终点
- Change of Thigh Circumference From Baseline
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of the Trusculpt (Radio Frequency) device in the reduction of thigh circumference.
详细描述
The primary efficacy variable for this study is the comparison of mean change in thigh circumference from baseline to 12 weeks between two arms. The primary research hypothesis is that the mean change in thigh circumference is ≥ 1 cm (indicating mean reduction).
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Minimum age of 18 years
- •Non-smoking for at least 3 months and willing to refrain from smoking for the duration of the study.
- •Post-menopausal, or on birth control and/or no plans to become pregnant for the duration of the study.
- •Body Mass Index (BMI) ≤ 30
- •Visible fat in the thigh / saddlebag area to be treated
- •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, and agree to maintain the same weight throughout the study (within 6 lbs of the weight measure at the baseline assessment)
排除标准
- •Taking weight-loss medications/supplements
- •Simultaneous participation in any other clinical study
- •Prior surgical treatment to the target area, e.g., liposuction or abdominoplasty
- •Prior treatment to the target area within the last 12 months e.g., radio frequency or cryolysis
- •Arteriosclerosis or weakened blood vessels
- •Heart disease
- •Thromboembolic disease
- •Diagnosed or documented immune system disorders (including Panniculitis)
- •Bleeding disorders
- •Presence of uncontrolled hypertension
- •Taking prescription anticoagulants
- •History of keloid formation
- •History of 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, large moles
- •Infection in the target area
- •Implanted electrical device(s) or metallic implants
- •Pregnant or lactating
结局指标
主要结局
Change of Thigh Circumference From Baseline
时间窗: Comparison of Baseline to 12 weeks post- final treatment
Change in thigh circumference from baseline of the treated thigh compared to the non-treated contra-lateral side at 12 weeks post-final treatment.
次要结局
未报告次要终点
研究者
研究点 (6)
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