Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-06-11 @ 2:37 PM
Study NCT ID:
NCT05527132
Status:
UNKNOWN
Last Update Posted:
2023-11-08
First Post:
2022-08-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Understanding the Phenomena of Aging and Rupture of Breast Implants
Sponsor:
University Hospital, Strasbourg, France
Organization:
Study Overview
Official Title:
Understanding the Phenomena of Aging and Rupture of Breast Implants
Status:
UNKNOWN
Status Verified Date:
2023-11
Last Known Status:
RECRUITING
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:
CRIMA
Brief Summary:
Breast implants, like all implantable medical devices, are subject to wear and tear as they age in the body. In addition to this wear and tear, they are subject to external trauma, whether accidental during daily life, during insertion or during mammography.
The kinetics and mechanisms of aging are poorly studied and the phenomenon of implant rupture is not elucidated. However, studies of older generation implants have shown that implant rupture is correlated with the duration of implantation.
The kinetics and mechanisms of aging are poorly studied and the phenomenon of implant rupture is not elucidated. However, studies of older generation implants have shown that implant rupture is correlated with the duration of implantation.
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?: