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RECRUITING
NCT06510205

The Study is an Oberservational Post-market Follow-up Program to Evaluate Long Term(5 Years) Safety of Mentor Breast Implants in Chinese Population.

Sponsor: Johnson & Johnson Medical (Shanghai) Ltd.

View on ClinicalTrials.gov

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 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 a minimum of 300 subjects per license, with participation from three or more medical institutions.

Official title: Post-Market Clinical Follow-up for Mentor Breast Implants

Key Details

Gender

FEMALE

Age Range

22 Years - 100 Years

Study Type

OBSERVATIONAL

Enrollment

5000

Start Date

2024-07-14

Completion Date

2034-12-31

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

DEVICE

Mentor Breast implants

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.

Locations (3)

Sichuan Huamei Zixin Medical Aesthetic Hospital

Chengdu, China

Shenzhen Yixing Medical Cosmetology Hospital

Shenzhen, China

Shenzhen Junke Medical Cosmetology Clinic

Shenzhen, China