Evaluation of the Safety and Efficacy of a Non-Invasive Disruption of Fat and Skin Tightening Using 1064nm and 940nm Wavelengths
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Ultrasound Measurement to Evaluate Reduction of Fat
研究概览
简要总结
The purpose of this study is to evaluate and compare the safety and pre-cursors of efficacy of a non-invasive 1064nm laser and 940nm diode, for the disruption of subcutaneous adipose tissue and skin tightening.
详细描述
The purpose of the biopsies is to assess if the device causes an inflammatory response in the abdominoplasty tissue that will be excised.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-smoking subjects between ages of 20-55 years of age 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 (Group 2 and 3) 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 VI.
- •Subjects (Group 2 and 3) who are willing to consent to participate in the study will be asked to undergo treatment, elasticity and ultrasound measurements, 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
- •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 determines based on the standard of care
结局指标
主要结局
Ultrasound Measurement to Evaluate Reduction of Fat
时间窗: 6 months post treatment
Ultrasound of the treatment area will be performed and evaluated in comparison to the baseline results to determine reduction of fat
Biopsy of Tissue Sample as a Measure of Effectiveness
时间窗: 6 months post treatment
Biopsy of treated area will be obtained up to 6 months post treatment and will be histologically assessed for changes in adipocytes, collagen and surrounding tissue to determine effectiveness of device
次要结局
- High Frequency Ultrasound to Measure Skin Elasticity and Thickness(6 months post last treatment)