Pilot Study to Evaluate the Cutera RF Device for Reduction in Size of Localized Areas of the Body, Including, But Not Limited to, Areas on the Abdomen, Leg, and Arm
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 76
- 试验地点
- 10
- 主要终点
- Change in Circumference (cm)
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 in size of localized areas of the body.
详细描述
The purpose of this study is to evaluate the Cutera radio frequency device for the new indication of reduction in size of localized areas of the body, including, but not limited to, areas on the abdomen, leg, and arm.
At investigator's discretion, each subject will receive up to three treatments and will be scheduled for two follow-up visits after the final treatment. The treated area will be measured and photographed ar 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
- 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or Male
- •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 with no plans to become pregnant for the duration of the study (female only)
- •Minimum Body Mass Index of 20
- •Visible fat in the area to be treated Area to be treated to measure at least 20.0mm 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, and agree to maintain the same weight throughout the study (within 6 lbs of initial weight)
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, large moles
- •Infection in the target area
- •Implanted electrical device(s)
- •Pregnant or lactating
结局指标
主要结局
Change in Circumference (cm)
时间窗: Baseline and 6 months post final treatment
次要结局
- Subject Satisfaction(Baseline and 6 months post final treatment)
- The Number of Participants With Adverse Events(Up to 6 months after the last treatment)