NCT03544593Unknown不适用
The Volumetric Analysis of Fat Grafting for Aesthetic Body Contouring
Hunstad Kortesis Bharti Cosmetic Sugrery2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年1月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Graft retention
研究概览
简要总结
Title: The Volumetric Analysis of Fat Grafting for Aesthetic Body Contouring.
Subjects who wish to undergo fat grafting for aesthetic body contouring will be offered enrollment to the study. The study will consist of a Screening/Baseline visit, Surgery day and 3 follow up visits. Each follow up visit will utilize Vectra 3D photography (Canfeild, NJ) to collect volumetric data. At the conclusion of the study, Volume data from Baseline and 3 follow up visits will be analyzed to determine fat retention rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Females or Males in good general health age 18 - 65 years of age
- •Must be willing to give and sign a HIPAA form and informed consent form
- •Must be willing and able to comply with all study protocols and schedules
- •Negative urine pregnancy test prior to surgery treatment (if applicable)
- •The patient must have had a stable weight (no fluctuation of >15 pounds in a year), diet, and physical activity for the previous 6 months
排除标准
- •Pregnancy, currently breast feeding or planning pregnancy for the duration of the trial
- •History of breast cancer if fat grafting to breasts
- •Patients who smoke or use nicotine products
- •Any UNCONTROLLED systemic disease -a potential patient in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study
- •Diabetes Mellitus
- •Subject has a clinically significant coagulation disorder or disease, defined as a platelet count < 100,000 per microliter or International Normalized Ratio > 1.5 within 4 weeks of surgery
- •Patients under the age of 18
- •Patients undergoing fat grafting but refuse enrollment
- •Patients with an active infection
- •Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.
结局指标
主要结局
Graft retention
时间窗: 9 months
Vectra 3D volumetric analysis will be utilized to evaluate graft retention.
次要结局
- Operating room time (harvesting, processing, and reinjection time) (min)(Intra Op)
- Standardized before and after photos(Pre op, 3 months, 6 months, 9 months)
- Volume of adipose harvested (mL)(Intra Op)
- Volume of adipocyte injected (mL)(Intra Op)
研究者
Bill G Kortesis, MD
PI
Hunstad Kortesis Bharti Cosmetic Sugrery
研究点 (2)
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