NCT07068061尚未招募不适用
Evaluation of the Performance and Safety of Polydioxanone Suture (PDO) "Bio Meyisun" for the Temporary Correction of the Mid-face Area.
21 Century Medical Co., Ltd.0 个研究点目标入组 50 人开始时间: 2025年9月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- The assessment of improvement in mid-face appearance.
研究概览
简要总结
This clinical investigation aims to confirm the safety and efficacy of the ID in facial soft tissue reconstruction, specifically for non-incision surgery to tighten and lift the facial skin for a rejuvenated facial appearance.
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
- •Patients over 18 years old with full legal capacity, male and female;
- •Patients with ability to understand the proposed aesthetic correction and to understand and sign informed consent;
- •Patients who are willing and able to comply with scheduled visits, aesthetic correction procedure and other trial procedures.
排除标准
- •Pregnant or breast--feeding women;
- •Patients currently participating in any other clinical investigation;
- •Patients who have received a vaccine within 14 days prior to the baseline or plan to have vaccine within 14 days after the injection;
- •Patients with a medical history of systemic diseases, including severe kidney, liver, heart and neurological disorders.
结局指标
主要结局
The assessment of improvement in mid-face appearance.
时间窗: up to 24 weeks
Proportion of subjects with any improvement compared to baseline, as assessed by the Independend Evaluator (IE).
次要结局
- Further evaluation of improvement of the mid-face appearance.(up to 35 weeks)
- Self-evaluation of improvement of the mid-face appearance by the Subject.(up to 35 weeks)
- Number of (S)AEs.(up to 35 weeks)
研究者
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