The Study is an Observational Post-market Follow-up Program to Evaluate Long Term (5 Years) Safety of Mentor Breast Implants in Chinese Population
Recruiting now
Conditions studied: Breast Augmentation, Mammaplasty
In brief
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.
Key facts
- Study ID
- NCT06510205
- Run by
- Johnson & Johnson Medical (Shanghai) Ltd.
- People needed
- 6111
- Starts
- 2024-07-14
- Expected to finish
- 2034-12-31
- Last updated by the study team
- 2026-07-31
Who can join
Age: 18 and older, up to 100. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- Not applicable
Where it is running
- Sichuan Huamei Zixin Medical Aesthetic Hospital — Chengdu, China (enrolling)
- Yunnan Huamei Meilai Cosmetology Hospital — Kunming, China (enrolling)
- Shenzhen Yixing Medical Cosmetology Hospital — Shenzhen, China (enrolling)
- Shenzhen Junke Medical Cosmetology Clinic — Shenzhen, China (enrolling)
Full record on ClinicalTrials.gov
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