Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-03-02 @ 5:17 PM
Study NCT ID:
NCT06510205
Status:
RECRUITING
Last Update Posted:
2025-10-10
First Post:
2024-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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.
Organization:
Study Overview
Official Title:
Post-Market Clinical Follow-up for Mentor Breast Implants
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| MNT202401 | OTHER | Johnson & Johnson Medical (Shanghai) Ltd | View |