CONtrolled Focal Fibrous Band Release Method Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 18
- 主要终点
- The Mean Change From Baseline to 3 Months in Cellulite Severity Scale (CSS) Score for Participants
研究概览
简要总结
Study to evaluate the safety and effectiveness of the Avéli medical device to reduce the appearance of cellulite.
详细描述
Multi-center, single-arm clinical study to evaluate the safety and effectiveness of the Avéli device in reducing the appearance of cellulite.
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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Moderate to severe cellulite
排除标准
- •Body Mass Index ≥30.0
结局指标
主要结局
The Mean Change From Baseline to 3 Months in Cellulite Severity Scale (CSS) Score for Participants
时间窗: 3 months
The CSS includes a 6-point (range of 0-5) and will be determined by 3 independent, blinded physician assessors of images obtained before and 3-months after treatment. CSS Scale TOTAL CSS SCORE: = (PART A + PART B) - 1 PART A- Number of evident depressions 0 None 1. Mild (≤4 depressions) 2. Moderate (5 to 9 depressions) 3. Severe (≥ 10 depressions) PART B - Average depth of depressions 0 None 1. Mild (1-2 mm) 2. Moderate (3-4 mm) 3. Severe (≥5 mm)
次要结局
- The Mean Change From Baseline to 12 Months in Cellulite Severity Scale (CSS) Score for Participants(12 months)
- Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 3 Months(3 months)
- Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 12 Months(12 Months)
- The Percentage of Patients Satisfied With Their Results at 3 Months(3 month)
- The Number of Patients Satisfied With Their Results at 12 Months(12 Months)