Status:
RECRUITING
The Study is an Oberservational Post-market Follow-up Program to Evaluate Long Term(5 Years) Safety of Mentor Breast Implants in Chinese Population.
Lead Sponsor:
Johnson & Johnson Medical (Shanghai) Ltd.
Conditions:
Breast Augmentation and Breast Reconstruction
Eligibility:
FEMALE
22-100 years
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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.
- Participants must be at least 22 years old at the time of their implantation surgery.
Exclusion
- Not applicable
Key Trial Info
Start Date :
July 14 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2034
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT06510205
Start Date
July 14 2024
End Date
December 31 2034
Last Update
October 10 2025
Active Locations (3)
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1
Sichuan Huamei Zixin Medical Aesthetic Hospital
Chengdu, China, 610000
2
Shenzhen Yixing Medical Cosmetology Hospital
Shenzhen, China, 518000
3
Shenzhen Junke Medical Cosmetology Clinic
Shenzhen, China, 519000