NCT06510205招募中不适用
MNT202401: Post Market Clinical Follow up for Mentor Breast Implants
Johnson & Johnson Medical (Shanghai) Ltd.4 个研究点 分布在 1 个国家目标入组 6,111 人开始时间: 2024年7月14日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 6,111
- 试验地点
- 4
- 主要终点
- Breast implant related AEs
研究概览
简要总结
The Mentor Post-Market Clinical Follow-Up Study is a multicenter observational study conducted in China. It aims to collect safety data on Mentor breast implants over a 5-year follow-up period in the Chinese population. In addition to safety data, the study will also gather information on postoperative pain and participant satisfaction levels. The objective is to explore customers' clinical experiences and use them as a reference for future product development. The study intends to enroll different number of participants for each license.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who have received Mentor breast implants per product instructions;
- •Participants must possess the ability to comprehend the study procedures, give consent for the use of their preoperative and surgical data, and agree to take part in postoperative follow-up assessments. Additionally, they should possess the necessary civil capacity, be capable of reading and writing, and willingly provide informed consent by signing the consent form.
- •Aged not less than 18 years at the time of implantation surgery (for products with registration license Guoxie Zhujin 20223130323, the participant's age should be not less than 22 years).
排除标准
- •Not applicable
研究组 & 干预措施
Mentor Group
Who recieves Mentor breast implants per request
干预措施: Mentor Breast implants (Device)
结局指标
主要结局
Breast implant related AEs
时间窗: Up to 5 years
Post-op 1 month, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years
次要结局
- Numerical Pain Scale assessment(1 month after surgery)
- Customer Satisfaction Score measurement(Up to 5 years after surgery)
研究者
研究点 (4)
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