Pilot Study of Non-Invasive Fat Layer Reduction in the Flanks of Asian Patients With the CoolCurve+ Applicator
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
- 1
- 主要终点
- Proportion of Pre-treatment Images Correctly Identified
研究概览
简要总结
This study will evaluate CoolSculpting and the CoolCurve applicator for non-invasive fat reduction in the flanks with sharp body curvature.
详细描述
The purpose of this study is to evaluate the performance of the CoolCurve+ applicator for non-invasive fat layer reduction in flanks for Asian patient population.
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.
- •Subjects must be of Asian descent.
- •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 with sharp flank curvature that fits well with the CoolCurve+ applicator.
- •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, 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 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 for weight loss 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 4 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: Baseline and 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 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 and 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. Success is defined as 70% correct identification of pre-treatment images.
Safety of the CoolSculpting and the CoolCurve+ Applicator
时间窗: Enrollment through 12 weeks post-final treatment
The number of device- or procedure-related adverse events will be tabulated for all AEs reported continuously throughout the study, from enrollment to the final 12 week follow-up visit.
次要结局
- Operator Feedback(Pre-treatment/treatment day)
- Subject Satisfaction With the Procedure(12 weeks post final treatment)
- Change in the Fat Layer Thickness(Pre-treatment and 12 weeks post-final treatment)