Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06510205
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-05
Brief Title:
The Study is an Oberservational Post-market Follow-up Program to Evaluate Long Term5 Years Safety of Mentor Breast Implants in Chinese Population
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Post-Market Clinical Follow-up for Mentor Breast Implants
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None