NCT03304925Unknown不适用
CoolSculpting the Flanks
Zeltiq Aesthetics13 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2017年10月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 320
- 试验地点
- 13
- 主要终点
- Effectiveness endpoint gauged by reduction in fat layer thickness
研究概览
简要总结
Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the flanks.
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
- 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 flanks, which in the investigator's opinion, may benefit from the treatment.
- •No weight change exceeding 5% of body weight 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%) 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, 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 8 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
Effectiveness endpoint gauged by reduction in fat layer thickness
时间窗: Final post-treatment visit
Reduction in fat layer thickness as measured by ultrasound at the final post-treatment visit.
Safety endpoint in relation to adverse events
时间窗: Final post treatment visit
Measurement of device- or procedure-related adverse events. It is expected there will be zero UADEs
次要结局
- Subject survey(Final post-treatment visit)
- Photo review(Final post-treatment visit)
研究者
研究点 (13)
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