NCT05746078招募中不适用
Long-term Assessment of the Performance and Safety of SPRING THREAD® Elastic Tensor Thread.
1st SurgiConcept2 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2023年2月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Investigator Global Aesthetic Improvement Scale (IGAIS)
研究概览
简要总结
The purpose of this post-market clinical follow up study is to assess the safety and effectiveness of the SPRING THREAD® elastic tensor thread. The study will evaluate the outcome of the SPRING THREAD® elastic tensor thread range over a period of 5 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men / women aged 35 to 75 with facial ptosis (cheekbones, jowls) with or without a history of aesthetic treatment (botox, filler, surgical lift).
- •Patient able to understand the explanations given.
- •Patient informed and not objecting to participate in the study.
- •Patient able to comply with protocol requirements, including follow-up visits.
- •Patient affiliated to social security.
排除标准
- •Patient unable to understand study information and attend study visits.
- •Patient did not give consent to participate.
- •Patients who have had a previous facial rejuvenation treatment in the 3 months prior to the study.
- •Patients treated with long-term systemic corticosteroids.
- •Patients with visceral failure, chronic immunological pathology, pregnant or breasfeading women.
- •Patient participating or having participated in another clinical trial protocol, drug or medical device within 30 days of inclusion.
- •Patient refusing to participate in the clinical investigation.
结局指标
主要结局
Investigator Global Aesthetic Improvement Scale (IGAIS)
时间窗: At 12 months
Proportion of patients with an IGAIS score between 1 and 3 showing an improvement of ptosis. This item is scaled from 1 to 5, 5 being the worst value.
次要结局
- Improvement of overall facial appearance(Day 0 to Year 5.)
- Patient satisfaction with SGAIS score (Subject Global Aesthetic Improvement Scale)(Day 0 to Year 5.)
- Age of face(Day 0 to year 5.)
- Safety of SPRING THREAD® Elastic Tensor Thread(Day 0 to month 12.)
- Surgeon satisfaction with IGAIS score (Investigator Global Aesthetic Improvement Scale)(Day 0 to month 24)
研究者
研究点 (2)
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