Safety Evaluation of Multiple CoolSculpting Treatments
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 6
- 主要终点
- Evaluation of Liver- Related Tests Over Time
研究概览
简要总结
To evaluate the safety of same-day CoolSculpting treatments and to assess the impact on serum lipids and liver-related tests.
详细描述
The study will evaluate the safety of multiple same-day CoolSculpting treatments and will assess any impact on serum lips or liver-related analytes,
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 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.
- •Subject who has been assessed to receive multiple CoolSculpting treatments on the abdomen and flanks, defined as follows:
- •Lower Abdomen - One 60 minute cycle with CoolMax,
- •Right and Left Flank - One 60 minute cycle per flank, with CoolCurve+ or CoolCore, simultaneously.
- •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 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 an invasive (e.g., liposuction, mesotherapy, abdominoplasty) or 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 history of hernia in the area(s) to be treated.
- •Subject is pregnant or intending to become pregnant during the study period (in the next 4 months).
- •Subject is lactating or has been lactating during the past 3 months.
- •Subject is unable or unwilling to comply with the study requirements, such as blood draw.
- •Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
- •Subject has a history of lipodosis or other confounding metabolic diseases.
- •Subject is taking or has taken medication within the past 3 months which may affect the metabolic function.
- •Patient has a history of diabetes.
- •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
Evaluation of Liver- Related Tests Over Time
时间窗: Pre-treatment; 1 week, 4 weeks, and 12 weeks post-treatment
Blood draws will be collected pre-treatment, 1-week, 4-weeks, 12-weeks post treatment. Changes in each analyte was evaluated for consistency with normal variation and for change relative to the reference range of the component (high/low), pre-treatment versus post-treatment by an independent physician. The independent physician reviewer was provided with laboratory results and other pertinent information for each subject, including demographic, medical history, and concomitant medications. For every change in laboratory value over time, the reviewer was required to make a determination of whether the change in value represented a clinically meaningful change. In addition, for any change in a laboratory value that exceeded 25% change, or any value outside of normal range, the reviewer was required to provide a written rationale for the determination of clinical meaningfulness.
Safety of the Device and/or Procedure as Assessed by the Incidence of SAE and UADE
时间窗: 12 weeks post treatment
The primary safety end point is the incidence of Serious Adverse Events (SAE) and Unanticipated Adverse Device Effects (UADE).
Evaluation of Liver-Related Tests Over Time
时间窗: Pretreatment, 1 week, 4 weeks 12 weeks post-treatment
Blood draws will be collected pre-treatment, 1-week, 4-weeks, 12-weeks post treatment. Changes in each analyte was evaluated for consistency with normal variation and for change relative to the reference range of the component (high/low), pre-treatment versus post-treatment by an independent physician. The independent physician reviewer was provided with laboratory results and other pertinent information for each subject, including demographic, medical history, and concomitant medications. For every change in laboratory values over time, the reviewer was required to make a determination of whether the change in value represented a clinically meaningful change. In addition, for any change in a laboratory value that exceeded 25% change, or any value outside of normal range, the reviewer was required to provide a written rationale for the determination of clinical meaningfulness.
Evaluation of Serum Lipid Values Over Time
时间窗: Pre-treatment, 1 week, 4 weeks, 12 weeks post-treatment
Blood draws will be collected pre-treatment, 1-week, 4-weeks, 12-weeks post treatment. Changes in each analyte was evaluated for consistency with normal variation and for change relative to the reference range of the component (high/low), pre-treatment versus post-treatment by an independent physician. The independent physician reviewer was provided with laboratory results and other pertinent information for each subject, including demographic, medical history, and concomitant medications. For every change in laboratory values over time, the reviewer was required to make a determination of whether the change in value represented a clinically meaningful change. In addition, for any change in a laboratory value that exceeded 25% change, or any value outside of normal range, the reviewer was required to provide a written rationale for the determination of clinical meaningfulness.
次要结局
- Side Effects in Treatment Area(Treatment day and 12 week post-treatment follow-up)
- Pain: Assessment of Pain Scores Reported on the Day of Treatment and at 12 Weeks Post-treatment.(Treatment day and 12 week post-treatment follow-up)
- Safety as Evaluated by the Number and Severity of All Reported Adverse Events.(12 weeks post-treatment)