NCT03800563已完成不适用
The Safety and Efficacy of Laser Assisted Liposuction and Facial Autologous Fat Grafting With the LipoLife System
Alma Lasers3 个研究点 分布在 2 个国家目标入组 20 人开始时间: 2018年11月6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
- 20
- 试验地点
- 3
- 主要终点
- Correct Identification of Before and After Photographs
研究概览
简要总结
Multi-center, prospective, open-label, single arm study. The study aims to evaluate the safety and efficacy of Laser Assisted Liposuction procedure performed with the LipoLife system. The study will include twenty (20) eligible subjects, that are willing to undergo abdominal or outer thighs laser-assisted liposuction. Five to twenty (5-20) subjects out of this study group should also be eligible for facial fat grafting. Follow up visits to evaluate study endpoints will take place at 1, 3 and 6 months after the surgery.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with excessive fat in the lower abdomen or subjects with excessive fat in the outer thighs that are willing to undergo laser-assisted liposuction
- •Estimated fat harvesting of 1-3 liters
- •Subjects (5-20) eligible for facial fat grafting of at least 5 cc for each cheek
- •Between 18 and 70 years of age
- •Provided written Informed Consent
排除标准
- •Body Mass Index (BMI) >35
- •Sever skin laxity
- •Positive pregnancy test
- •Current smoker
- •Presence of known malignancy
- •Active infection in the treatment area
- •History of autoimmune disorder (e.g., Systemic Lupus Erythematosus [SLE])
- •History of connective, metabolic or atrophic skin disease
- •History of keloid scarring
- •Chronic use (>7 consecutive days) of anticoagulants (such as aspirin) or NSAIDs within 15 days prior to enrollment
- •Subjects with immune system diseases
- •Subject unable to follow post-treatment instructions
- •Any other reason that in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety.
结局指标
主要结局
Correct Identification of Before and After Photographs
时间窗: 3 months
Over 90% success in correct identification of before and after body contouring photos by blinded evaluators.
次要结局
未报告次要终点
研究者
研究点 (3)
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