NCT01391923已完成不适用
Non-Invasive Reduction of Fat in the Arms With the CoolFlex Applicator
Zeltiq Aesthetics4 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年7月1日最近更新:
适应症
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
- 4
- 主要终点
- Independent imaging review
研究概览
简要总结
This study is being performed to reduce unwanted fat in the arm using a new applicator for the Zeltiq System.
详细描述
The primary objective of the study is to evaluate the safety and performance of the CoolFlex applicator in the flat configuration for reduction of fat in the upper arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 and < 65 years of age.
- •Subject has clearly visible fat on the underside of the upper arm, generally located over the triceps muscle. (Figure 1)
- •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.
- •Subject has had an invasive fat reduction procedure (e.g., liposuction or 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 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, such as moderate to excessive skin laxity, 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
Independent imaging review
时间窗: 16 weeks
Performance will be evaluated by changes in the contour as established by blinded photographic review of a series of pre- and 16-week post-treatment images for each subject.
次要结局
未报告次要终点
研究者
研究点 (4)
Loading locations...
相似试验
已完成
不适用
Non-Invasive Reduction of Abdominal FatFat ReductionNCT01101997Zeltiq Aesthetics60
已完成
不适用
Pilot Study of CoolTXT for Non-Invasive Fat ReductionBody Fat DisorderNCT01517646Zeltiq Aesthetics18
已完成
不适用
Non-Invasive Reduction of Abdominal Fat Utilizing the CoolFlex and eZ App 6.3 ApplicatorsFat Reduction in the AbdomenNCT01377740Zeltiq Aesthetics20
已完成
不适用
Pilot Study on The Flanks of Asian PatientsBody Fat DisorderNCT01623037Zeltiq Aesthetics15
已完成
不适用
CoolSculpting of the Flank With Alternate Treatment ParametersBody Fat DisorderNCT02081196Zeltiq Aesthetics45