CoolSculpting the Abdomen Using an Applicator With a Crown Cooling Insert
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Participants With Unanticipated Adverse Device Effects (UADE)
研究概览
简要总结
Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the abdomen using an applicator with the Crown Cooling Insert.
详细描述
Evaluation of CoolSculpting treatment in the abdomen using a vacuum applicator with an accessory insert.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 on the abdomen, which in the investigator's opinion, may benefit from the treatment.
- •Subject is a candidate for a standard CoolSculpting treatment with a CoolMax applicator.
- •No weight change exceeding 5% of body weight in the preceding month.
- •Subject agrees to maintain his/her weight (i.e., within 5%) 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
- •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, cold agglutinin disease 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 or any other metal containing implant.
- •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.
- •Subject is prone to severe claustrophobia (during MRI scans).
- •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
Participants With Unanticipated Adverse Device Effects (UADE)
时间窗: Enrollment through 12 weeks post-treatment
The number of unanticipated device effects will be tabulated to assess safety of the device and applicator accessory (Crown Cooling Insert). Adverse event data is collected from the time of enrollment through the 12 week follow-up visit.
Percentage of Accurately Identified Pre-treatment Photos
时间窗: 12 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. Success is defined as at least 70% correct identification of pre-treatment images by two out of three reviewers.
次要结局
- Subject Satisfaction Questionnaire(12 weeks post-final treatment)