NCT07739212已完成不适用
Retrospective Data Collection to Evaluate the Safety and Performance of Accent System / BiPolarRF for the Treatment of Approved Indications Data Collection Protocol
Alma Mater Europaea College of Medical Sciences "Rezonanca"1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年7月5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
- 150
- 试验地点
- 1
- 主要终点
- GAIS
研究概览
简要总结
This is a retrospective data collection from patients treated with the bipolar radiofrequency applicator (Coaxipolar) of the Accent devices. Patient files were screened for suitable candidates providing before and after treatment pictures for blinded evaluation. The safety and efficacy of bipolar RF technology, both as a standalone treatment and in combination with unipolar RF, for facial contouring and the reduction of wrinkles and fine lines is investigated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Healthy male or female ≥18 years old.
- •Complete Medical History records are available
- •Documented baseline and follow-up digital images are available
- •Treatment with one applicator only for the approved indication for bipolar applicator such as skin laxity, wrinkles and rhytids
- •provided consent for before and after (B&A) pictures for evaluation Fitzpatrick skin type I- VI
排除标准
- •Exclusions per the Operational Manual
结局指标
主要结局
GAIS
时间窗: From enrollment to the end of treatment at 24 weeks
Skin laxity was assessed using the Global Aesthetic Improvement Scale (GAIS; 0-4 scale), GAIS 5-point scale (0 = worse, 1 = no change, 2 = mild improvement, 3 = much improvement, 4 = very much improvement)
次要结局
- Fitzpatrick-wrinkle-scale(From enrollment to the end of treatment at 24 weeks)
- VISIA Score Change (if applicable)(From enrollment to the end of treatment at 24 weeks)
- Patient satisfaction (if applicable)(From enrollment to the end of treatment at 24 weeks)
研究者
研究点 (1)
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