DualSculpting the Upper Arms Using Vacuum Applicators and a Customized Treatment Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Proportion of Correctly Identified Pre-treatment Photos
研究概览
简要总结
Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using specialized vacuum applicators for non-invasive subcutaneous fat reduction of the upper arms.
详细描述
Subcutaneous fat reduction of the upper arms using 2 vacuum applicator types will be done concurrently, such that a subject will have an applicator placed on each arm simultaneously.
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
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects > 22 years of age and < 65 years of age.
- •Subject has clearly visible fat sufficient for treatment on the upper arm, which in the investigator's opinion, may benefit from the treatment.
- •No weight change exceeding 5% in the preceding month.
- •Subject agrees to maintain his/her weight (i.e., within 5% of total body weight) by not making any major changes in their diet or exercise routine during the course of the study.
- •Subject has read and signed the study written informed consent form.
排除标准
- •History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.), or implants in or adjacent to the area of intended treatment.
- •History of prior surgery in the arms.
- •Known history of cryoglobulinemia, cold urticaria, cold agglutinin disease, or paroxysmal cold hemoglobinuria.
- •Known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
- •History of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
- •History of carpal tunnel syndrome, compartment syndrome or deep vein thrombosis in the upper extremities.
- •Currently taking or has taken diet pills or weight control supplements within the past month.
- •Any dermatological conditions, such as scars, infection, in the location of the treatment area that may interfere with the treatment or evaluation.
- •Active implanted device such as a pacemaker, defibrillator, or drug delivery system.
- •Pregnant or intending to become pregnant in the next 5 months.
- •Lactating or has been lactating in the past 6 months.
- •Unable or unwilling to comply with the study requirements.
- •Currently enrolled in a clinical study of any other unapproved investigational drug or device. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
结局指标
主要结局
Proportion of Correctly Identified Pre-treatment Photos
时间窗: 12 weeks post-final treatment
Change in the treated vs. untreated areas will be assessed by observation of changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images. Reviewers are practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images are presented will be randomized; for each subject placement of the baseline, pre-treatment image will be randomized for each pair of subject images. Reviewers will be asked to select the baseline photos for each subject photo series and record selections on a data collection form. Criteria for evaluable photos for the purposes of the independent review: subject completed treatment regimen; subject has complete set of baseline photos; subject has a complete set of post-treatment photos; photos were taken using Zeltiq standard procedure. The expected success rate is 70% correct identification by 2 out of 3 reviewers.
Number of Participants With Unanticipated Adverse Device Effects (UADE) Associated With the CoolSculpting System and Vacuum Applicators in the Upper Arms
时间窗: Enrollment through12 weeks post-final treatment
The primary safety endpoint of the study is the incidence of unanticipated adverse device effects (UADE) reported in the study period. Investigators assessed each adverse event to determine if there was relationship to the study device or procedure. Adverse event data are collected from the time of study enrollment through the final follow-up visit at 12 weeks post-treatment.
次要结局
未报告次要终点