Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-29 @ 3:54 AM
Study NCT ID:
NCT04060134
Status:
COMPLETED
Last Update Posted:
2024-02-14
First Post:
2019-08-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Retrospective Breast Reconstruction Study
Sponsor:
Elutia Inc.
Organization:
Study Overview
Official Title:
A Retrospective, Multi-Center, Open Label Study Evaluating SimpliDerm™ and Other Human Acellular Dermal Matrices in Breast Reconstruction
Status:
COMPLETED
Status Verified Date:
2024-02
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:
To collect data on patients who have previously undergone breast reconstruction utilizing SimpliDerm and other HADMs.
Detailed Description:
This study is a retrospective, multi-center, open label study evaluating SimpliDerm and other human acellular dermal matrices in breast reconstruction.
A total of up to 300 patients who underwent direct to implant (one stage) or two-stage unilateral or bilateral breast reconstruction with SimpliDerm an other HADMs at the time of implant or TE placement.
Data will be collected for a minimum of one post-surgical visit after direct implant or exchange. If more visits are available, data from those visits will be collected as well.
A total of up to 300 patients who underwent direct to implant (one stage) or two-stage unilateral or bilateral breast reconstruction with SimpliDerm an other HADMs at the time of implant or TE placement.
Data will be collected for a minimum of one post-surgical visit after direct implant or exchange. If more visits are available, data from those visits will be collected as well.
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?: