Clinical Study to Evaluate the Performances of Modified VelaShape and the Performance of Contour I V3 Devices for Abdominal Fat Reduction vs. Control
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- histology following VelaShape treatment
研究概览
简要总结
Prospective, 2-arm, clinical study for the evaluation of the VelaShape device and Contour I V3 device for non-invasive fat reduction vs. control.
All study subjects, who are scheduled for abdominoplasty, will undergo one treatment with VelaShape or Contour I V3 device.
Each arm will be treated with a different device:
Arm 1: subject will treated with VelaShape device Arm 2: subject will treated with Contour I V3 device
详细描述
Eligible subjects will undergo one treatment on one abdominal subarea. Another abdominal subarea will remain without treatment and will serve as a control. Biopsies from treated and untreated areas will be harvested during abdominoplasty and cultured.. Treatment with VelaShape will be performed to arm 1, and treatment with Contour I V3 will be performed to arm 2, according to the study protocol.
Each arm will be divided into 6 sub-groups, according to the following time interval between VelaShape or UltraShape treatment to surgery:
Sub-group 1: Surgery immediately after treatment Sub-group 2: Surgery 10 days after treatment Sub-group 3: Surgery 20 days after treatment Sub-group 4: Surgery 30 days after treatment Sub-group 5: Surgery 60 days after treatment Sub-group 6: Surgery 90 days after treatment Each Sub-group contains up to 2 subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent to participate in the study.
- •Scheduled date for surgery (abdominoplasty).
- •Agree to provide samples for histology from the abdominoplasty.
- •Female and male subjects, between 18 to 60 years of age at the time of enrollment
- •Fitzpatrick Skin Type I to VI.
- •For Contour I V3 treatment only: Abdominal fat thickness of at least 1.5 cm (measured by calibrated caliper).
- •Female subjects must be either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide or abstinence).
- •General good health confirmed by medical history and skin examination of the treated area.
- •Willing to follow the treatment and to provide histology samples during the surgery from the intended to be harvested areas.
- •Willingness to refrain from a change in diet/ exercise/medication regimen for the entire course of the study.
- •Willing to have photographs and images taken of the treated areas to be used (with de-identification) in evaluations, publications and presentations
排除标准
- •A subject is not eligible for participation in this study if he/she meets any of the following exclusion criteria:
- •History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator, or abdominal aortic aneurism
- •Not intended to undergo surgery (abdominoplasty)
- •Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease
- •Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or pre-malignant pigmented lesions
- •Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator
- •Having a permanent implant in the treated area, such as metal plates, or an injected chemical substance such as silicone
- •Having undergone any other surgery in the treatment area within 12 months of treatment or during the study, including liposuction
- •Previous body contouring procedures in the treatment area within 12 months
- •History of skin disease in the treatment area, known tendency to form keloids or poor wound healing Known photosensitivity
- •Suffering from significant skin conditions in the treatment area or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions and active cold sores or herpes sores prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course
- •Skin lesions in the treatment area other than simple nevi on physical examination (e.g., atypical nevus, tattoo, abrasions) including depressed scars in the treatment area
- •Very poor skin quality (i.e., severe laxity)
- •Abdominal wall diastasis or hernia on physical examination
- •Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months
- •Any acute or chronic condition which, in the opinion of the investigator, could interfere with the conduct of the study
- •Unstable weight within the last 6 months (i.e., more than ± 3% weight change in the prior 6 months)
- •Participation in another clinical study within the last 6 months.
- •As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
结局指标
主要结局
histology following VelaShape treatment
时间窗: day 10 up to 90 days
Evaluate abdominal fat reduction post VelaShape treatment vs.control
Histology following Contour I V3 treatment
时间窗: day 10 up to 90 days
Evaluate Abdominal fat reduction post Contour I V3 treatment vs. control
次要结局
未报告次要终点