An Evaluation of the Effect of the Erchonia Corporation Violet Zerona® Z6 for Body Contouring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Combined Circumference Reduction in Inches of the Waist, Hips, and Bilateral Thighs
研究概览
简要总结
The purpose of this clinical study is to determine the effectiveness of the Erchonia® Violet Zerona Z6 (manufactured by Erchonia Corporation (the Company), an over-the-counter (OTC) laser device, in providing noninvasive body circumference reduction.
详细描述
The clinical study is an open-label non-inferiority design to evaluate the efficacy of the Erchonia® Violet Zerona Z6, an over-the-counter (OTC) laser device, in providing noninvasive circumference reduction. The clinical study protocol is based on the protocol for the clinical study whose results were submitted in support of clearance of the predicate device, the Erchonia® Zerona® Z6 OTC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •BMI is 30 or less
- •18 years of age or older
排除标准
- •Open wounds (sores, cuts, ulcers, etc.)
- •Individuals with or being treated for any cancerous growth
结局指标
主要结局
Combined Circumference Reduction in Inches of the Waist, Hips, and Bilateral Thighs
时间窗: 2 weeks
Mean change in total combined circumference inches of the waist, hips and bilateral thighs from baseline to endpoint evaluation.
次要结局
未报告次要终点