该研究是一项观察性上市后随访计划，旨在评估 Mentor 乳房植入物在中国人群中的长期（5 年）安全性。
Mentor 乳房植入物的上市后临床随访
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.
研究概览
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Study Contact
- 电话号码：+86 15692105615
- 邮箱：ygu51@its.jnj.com
学习地点
-
-
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Chengdu、中国、610000
- 招聘中
- Sichuan Huamei Zixin Medical Aesthetic Hospital
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Kunming、中国、650000
- 招聘中
- Yunnan Huamei Meilai Cosmetology Hospital
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Shenzhen、中国、519000
- 招聘中
- Shenzhen Junke Medical Cosmetology Clinic
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Shenzhen、中国、518000
- 招聘中
- Shenzhen Yixing Medical Cosmetology Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
All populations receiving Mentor breast implants
描述
Inclusion Criteria:
- 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).
Exclusion Criteria:
- Not applicable
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Mentor Group
Who recieves Mentor breast implants per request |
Mentor breast implants are circular or waterdrop-shaped devices with shells made of successive cross-linked layers of silicone elastomer. The shell is filled with Mentor's proprietary formulation of silicone gel. Mentor breast implants are available in smooth and textured shells, both supplied in sterile form. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Breast implant related AEs
大体时间：Up to 5 years
|
Post-op 1 month, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years |
Up to 5 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Numerical Pain Scale assessment
大体时间：1 month after surgery
|
Zero means you have no pain, while 10 represents the most intense pain possible. |
1 month after surgery
|
|
Customer Satisfaction Score measurement
大体时间：Up to 5 years after surgery
|
Measured at 1 month, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years after surgery Using a 5-point scoring scale, 5 means very satisfied while 1 means very disatisfied. |
Up to 5 years after surgery
|
合作者和调查者
调查人员
- 研究主任：Huimin Wu、Shenzhen Junke Medical Cosmetology Clinic
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- MNT202401
- PMS-MTR-202301 (其他标识符：Johnson & Johnson Medical (Shanghai) Ltd.)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
The data sharing policy of Johnson & Johnson MedTech is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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