Non-Invasive Reduction of Abdominal Fat Utilizing the JUNO Applicator
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 10
- 主要终点
- Proportion of Pre-treatment Images Correctly Identified
研究概览
简要总结
This study is being performed to reduce unwanted abdominal fat using a new applicator for the Zeltiq System.
详细描述
The primary objective of the study is to achieve a discernable change to the contour of the abdominal area treated with the JUNO applicator that is consistent with that documented during a clinical study of a previous applicator used to treat lovehandles.
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 —（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.
- •Subject has clearly visible fat on the abdomen.
- •Subject has not had weight change exceeding 10 pounds in the preceding month.
- •Subject agrees to maintain their 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 in the past 6 months.
- •Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment within the past year.
- •Subject has had a non-invasive fat reduction procedure in the area of intended treatment within the past 6 months.
- •Subject 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 Reynaud'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 body mass index (BMI) exceeds
- •BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
- •Subject is taking or has taken diet pills or supplements within the past month.
- •Subject has any dermatological conditions or scars in the location of the treatment sites that may interfere with the treatment or evaluation.
- •Subject is pregnant or intending to become pregnant in the next 6 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
Proportion of Pre-treatment Images Correctly Identified
时间窗: 16 weeks
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 an average 80% correct identification by the three reviewers.
次要结局
- Subject Satisfaction(16 weeks)
- Change in the Fat Layer of the Treated Area as Measured by Ultrasound(16 weeks)