Clinical Study to Evaluate the Performance of the UltraShape Device for Fat Reduction Treatment in the Flanks Area vs. Control
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- efficacy of flank fat reduction vs. control
研究概览
简要总结
Prospective, blinded, one arm, baseline-controlled clinical study for the evaluation the performance of the UltraShape treatment for non-invasive fat reduction by compare control and treated flanks.
Study subjects will undergo UltraShape treatments on one randomized flank using the U-Sculpt/VDF Transducer. The second flank will not be treated (control). Both flanks (treated and control) will be compared to baseline, as well as, one to each other
详细描述
This study is a prospective, baseline and blinded controlled, comparison, clinical study showing the performance and safety of the UltraShape treatment for non-invasive fat reduction at the flanks area comparing improvement observed in treated versus control flanks.
Up to 60 Healthy subjects in up to 4 investigational sites will be enrolled in this study. All subjects will undergo an assessment of their general health. During the treatment period, subject's fat thickness will be measured on both flanks. Three successive bi-weekly (two weeks interval) UltraShape treatments will be performed on one randomized flank, while the second flank will not be treated and served as a control.
The study subjects will undergo UltraShape treatments on one flank using the U-Sculpt /VDF Transducer, the treated flank will remain steady along the study and will be comparing to the baseline and to the controlled flank Three follow-up visits will be conducted as follows: 4 weeks (4wk FU), 8 weeks (8wk FU) and 16 weeks (16wk FU) post last treatment (Tx.3).
Subject's fat thickness will be measured on both flanks in the measurements points using caliper at each visit (at treatment visits, prior to treatment). Ultrasound measurements will be taken at each visit, except for the second treatment visit, on each flank. Investigator satisfaction will be assessed at all FU visits. In addition, subject questionnaires will be completed at each follow-up visit. Photographs of the front, right, left and back view of each flank will be performed under visible light conditions at each study visit.
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, between 18 to 60 years of age at the time of enrolment
- •Fitzpatrick Skin Type I to VI.
- •Fat thickness of at least 1.5 cm in the treated area (measured by calibrated caliper).
- •BMI interval: BMI between 22 to 30 (normal to overweight, but not obese).
- •If female, not pregnant or lactating, 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 follow-up visit for women with child-bearing potential (e.g. not menopause).
- •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
- •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 above 30)
- •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)
- •Fat thickness lower than 2.5 cm after strapping at the treated area.
- •Participation in another clinical study involving same anatomical areas within the last 6 months (or 30 days in case different anatomical areas were treated in previous trial/s).
- •As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
研究组 & 干预措施
UltraShape treatment in all subjects
UltraShape treatment for fat reduction to unilateral flank for all subjects with untreated flank as control.
干预措施: UltraShape treatment (Device)
结局指标
主要结局
efficacy of flank fat reduction vs. control
时间窗: up to 16 weeks after treatment
Evaluate the efficacy of UltraShape treatments with the U-sculpt/VDF Transducer for flanks fat reduction as assessed by comparing the change during the study on the treated flank area and compare to the change observed on the un-treated (control) flank
次要结局
- Fat thickness reduction on the treated flank(4, 8 and 16 weeks)
- Investigator satisfaction assessment(4, 8 and 16 weeks)
- Subject satisfaction assessment(4, 8 and 16 weeks)
- pain assessment(day 0, 2 weeks and 4 weeks)
- Safety of flank fat reduction(up to 20 weeks after treatment)