NCT05517824已完成不适用
Efficacy and Safety of the Micro-insulated Needle Radiofrequency Device for Reduction of Submental Fat
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Physician-Assisted Submental Fat Rating Scale score from 0 (nothing) to 4 (very severe)
研究概览
简要总结
The investigators aimed to evaluate the efficacy and safety of a fractional radiofrequency device with a micro-insulated needle to reduce submental fat.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with excess submental fat on a grade of 1~4, as assessed by the Physician-Assisted Submental Fat Rating Scale
排除标准
- •mental impairment, infectious disease
- •history of keloid development
- •pregnancy, pacemaker
- •use of anticoagulants
- •undergoing a facelift procedure within the prior 6 months.
结局指标
主要结局
Physician-Assisted Submental Fat Rating Scale score from 0 (nothing) to 4 (very severe)
时间窗: 1 month after the treatment
submental fat rating by an independent investigator
次要结局
- submental fat volume (cc)(1 month after the treatment)
- patient satisfaction score from 0 (not satisfied) to 10 (most satisfied)(1 month after the treatment)
- any adverse effects at any time during or after treatment(assessed through study completion, an average of 2 months)
研究者
Jung-Won Shin
Associate Professor
Seoul National University Bundang Hospital
研究点 (2)
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