Non-Invasive Reduction of Subcutaneous Fat Layer With an Alternative Treatment Parameter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 6
- 主要终点
- The Number of Device and/or Procedure-Related Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction with an alternative treatment parameter.
详细描述
The study evaluated the use of the Zeltiq CooSculpting System for non-invasive fat removal in the flank.
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
- •Male or female subjects > 18 years of age and < 65 years of age.
- •Subject has clearly visible fat on the flanks, which in the investigator's opinion, may benefit from the treatment.
- •Subject has not had weight change exceeding 10 pounds in the preceding month.
- •Subject with body mass index (BMI) up to
- •BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
- •Subject agrees to maintain his/her weight (i.e., within 5 pounds) by not making any major changes in their diet or lifestyle during the course of the study.
- •Subject has read and signed a written informed consent form.
排除标准
- •Subject has had a surgical procedure(s) in the area of intended treatment.
- •Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
- •Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 12 months.
- •Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
- •Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
- •Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
- •Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
- •Subject is taking or has taken diet pills or supplements within the past month.
- •Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion).
- •Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system
- •Subject is pregnant or intending to become pregnant during the study period (in the next 5 months).
- •Subject is lactating or has been lactating in the past 6 months.
- •Subject has a history of hernia in the areas to be treated.
- •Subject is unable or unwilling to comply with the study requirements.
- •Subject is 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
The Number of Device and/or Procedure-Related Adverse Events
时间窗: Enrollment through 16 weeks post-treatment visit, which is approximately 5 months
The number of device- or procedure-related adverse events will be tabulated. Adverse event reports are collected throughout the study from enrollment through the 16 week follow-up visit. The investigator determines if there is a relationship between the event and the study device or procedure.
Change in the Fat Layer of the Treated Area as Measured by Ultrasound
时间窗: Pre-treatment and 16 weeks post-treatment
Change in the fat layer thickness will be calculated by comparison of pre-treatment and 16 week post-treatment ultrasound measurements taken in the area treated with the device, and in the untreated contralateral flank control area. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Overall fat layer thickness changes were normalized for each subject by subtracting the change in control from the change in treated area to remove the influence of weight variations. Success is defined as, on average, at least a 1mm or greater reduction in fat layer thickness for the treated flank as compared to the untreated control flank. Results indicate the fat layer reduction in millimeters.
次要结局
- Proportion of Pre-treatment Images Correctly Identified.(16 weeks post-treatment)
- Subject Satisfaction(16 weeks post-treatment)