NCT03430245已完成不适用
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for Thigh Circumference Reduction
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Circumference Change in the Thighs at the 12-week Follow-up Compared to Baseline Measurements
研究概览
简要总结
Prospective, one-arm, baseline-controlled pilot study for the evaluation of the VelaShape III combined with UltraShape Power treatment for non-invasive circumference reduction to the thighs.
详细描述
Eligible subjects will receive 3 bi-weekly treatments to the thighs at 2-week intervals, with the VelaShape III and UltraShape Power devices according to the study protocol.
Each subject will return for 3 follow up visits: four weeks (4wk FU), 8 weeks (8wk FU) and 12 weeks (12wk FU) after the last treatment (Tx.3), for total expected study duration of 16 weeks.
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 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.
- •Female and male subjects, 18 and 60 years of age at the time of enrollment.
- •Fitzpatrick Skin Type I to VI.
- •Fat thickness of at least 1.5 cm (measured by calibrated caliper).
- •BMI interval: 22 ≤ BMI ≤ 30 (normal to overweight, but not obese).
- •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).
- •In addition, negative urine pregnancy test as tested before each treatment and at the last visit for women with child-bearing potential (e.g. not menopausal).
- •General good health confirmed by medical history and skin examination of the treated area.
- •Willing to follow the treatment and follow-up schedule and post-treatment care instructions.
- •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 de-identified in evaluations, publications and presentations.
排除标准
- •History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator, abdominal aortic aneurism.
- •Known 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 treated areas 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 treated areas 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.
- •Obesity (BMI > 30).
- •Pregnant, childbirth within the last 12 months or breastfeeding women.
- •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., ± 3% weight change in the prior six months).
- •Inability to comply with circumference measurement procedure (e.g., inability to hold breath for the required duration).
- •Abdominal fat thickness lower than 2.5 cm after strapping.
- •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
Circumference Change in the Thighs at the 12-week Follow-up Compared to Baseline Measurements
时间窗: At 12 weeks after the third treatment (week 16) for each subject
Circumference change of thigh midline post combined VelaShape III and UltraShape Power treatments. Negative change represent reduction in thigh circumference.
次要结局
- Investigator Satisfaction(At 4, 8 and 12 weeks follow-up visits)
- Subject Satisfaction(At 4, 8 and 12 week follow-up visits)
- Change in the Thighs Circumference at Each Treatment Visit Post Baseline and at The 4 and 8 Week Follow-up Visits(At 2, 4, 8 and 12 weeks after baseline)
研究者
研究点 (2)
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