Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-27 @ 9:52 PM
Study NCT ID:
NCT01223066
Status:
WITHDRAWN
Last Update Posted:
2022-08-25
First Post:
2010-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Macrolane Prospective Survey
Sponsor:
Galderma R&D
Organization:
Study Overview
Official Title:
A Multi-center, Non-interventional, Prospective Study to Monitor Long Term Safety in Female Subjects After Treatment With Macrolane Volume Restoration Factor 20 and/or Macrolane Volume Restoration Factor 30 in the Breasts.
Status:
WITHDRAWN
Status Verified Date:
2012-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no patients recruited
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study objective is to evaluate the long term safety when Macrolane Volume Restoration Factor is used in female breasts in clinical practice.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: