NCT01842802已完成不适用
Clinical Investigation of Non Invasive Fat Reduction
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Biopsy of Tissue Samples as a Measure of Effectiveness
研究概览
简要总结
The purpose of this study is to compare non invasive treatments using a YAG and Didode Laser to reduce the volume of fat.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A healthy non-smoking male or female between 20-60 years of age
- •Subjects presenting excess abdominal tissue (fat and skin), are candidates for an abdominoplasty procedure and are willing to allow the use of this device on their skin
- •Subjects who will allow the excess skin removed as part of the abdominoplasty to be sent for laboratory analysis
- •Understand and accept the obligation associated with the procedure
- •Subjects with Fitzpatrick skin types I to III.
- •Subjects who are willing to consent to participate in the study will be asked to undergo biopsies, ultrasound measurements, and blood testing as outlined for each group and defined in section 6.
- •Subjects must agree to maintain the same diet and exercise regime throughout the study
排除标准
- •Any previous liposuction/lipo-sculpture or any type of procedure in the abdominal area in the past 6 months
- •A history of allergic reactions to medications or anesthesia required for the procedure
- •A history of thrombophlebitis
- •A history of acute infections
- •A history of heart failure
- •Received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin E or anti-inflammatories within 2 weeks pre treatment
- •Intolerance to anesthesia or medications to be prescribed before or after the procedure.
- •Any medical condition, that, in the investigator's opinion would interfere with the patient's participation in the study including EMLA cream or percocet
- •Taking medications that are photosensitive
- •A history of keloid formation
- •A study subject must not be pregnant or have been pregnant in the last 3 months
- •The physician has the right to make determination of eligibility as he/she deems clinically significant based on standard of care treatment
结局指标
主要结局
Biopsy of Tissue Samples as a Measure of Effectiveness
时间窗: 5 months post treatment
Biopsy of treated area will be obtained up to 5 months post treatment and will be histologically assessed for changes in adipocytes and surrounding tissue to determine effectiveness of device.
Ultrasound Measurement to Evaluate Reduction of Fat
时间窗: 5 months post treatment
Ultrasound of the treatment area will be performed and evaluated in comparison to baseline results to determine reduction of the subcutaneous fat layer.
次要结局
- Lipid level blood testing to evaluate changes post treatment(5 months post treatment)
研究者
研究点 (2)
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