Non-Invasive Reduction of Fat in the Inner Thighs With the Zeltiq Coolsculpting System
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
- Percentage of Pre-Treatment Images Correctly Identified by Reviewers
研究概览
简要总结
Evaluate the safety and efficacy of non-invasive fat reduction in the inner thighs with the ZELTIQ CoolSculpting System.
详细描述
The Zeltiq CoolSculpting System, which reduces subcutaneous fat in specific areas of the body, will be studied for safety and efficacy when used in the inner thigh.
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
盲法说明
Panel of blinded physicians evaluated photos of pre-treatment and post-treatment images. Reviewers were blinded to the time point images were collected.
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 inner thighs and 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 his/her 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, abdominoplasty, 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 6 months.
- •Subject needs to administer, or has a known history of, subcutaneous injections (e.g., heparin, insulin) into the area of intended treatment 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 a 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 intends to become pregnant in the next 8 months.
- •Subject is lactating or has been lactating in the past 6 months.
- •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
Percentage of Pre-Treatment Images Correctly Identified by Reviewers
时间窗: 16 weeks post-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 of the treated areas. Reviewers will be practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images will be 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. The expected success rate is at least 80% correct identification of pre-treatment images and the majority of physician reviewers (2 out 3) correctly identify 75% of the pre-treatment images.
Safety of the CoolSculpting Device and/or Procedure
时间窗: Enrollment through 16 weeks post-treatment
The number of device- or procedure related adverse events will be tabulated. Adverse event data are collected continuously throughout the study period from the time of enrollment through the 16 week follow-up visit. At the time of an AE report, each study investigator determines the relationship to the investigational device or the study procedure.
次要结局
- Subject Satisfaction(16 weeks post-treatment)
- Reduction in Fat Layer Thickness in the Treated Area as Measured by Ultrasound(16 week-post-treatment)