NCT01579487已完成不适用
Non-Invasive Reduction of Abdominal Fat Utilizing the JUNO Applicator
Zeltiq Aesthetics2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2012年3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
- 10
- 试验地点
- 2
- 主要终点
- Independent Photo Review
研究概览
简要总结
This study is being performed to follow up on subjects who participated in the initial study (ZA10-001) in 2010.
详细描述
The primary objective of this investigation is to assess the durability of treatment outcomes with the ZELTIQ System.
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
- •Subject participated in the ZA10-001 study, and received all study treatments.
- •Subject has read and signed a written informed consent form.
排除标准
- •Subject has had any surgical or aesthetic procedure(s) in or around the abdomen since the completion of the ZA10-001 study treatments.
- •Subject is pregnant.
- •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 integrity of the data.
结局指标
主要结局
Independent Photo Review
时间窗: 12+ mos post treatment
The primary effectiveness endpoint is the correct identification of the series of pre-treatment images by the three reviewers.
次要结局
- Access reduction(12+ mos post treatment)
- Subject Satisfaction(12+ mos post treatment)
研究者
研究点 (2)
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