Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05744414
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2023-02-09
Brief Title:
Histological Analysis of AlloMend Acellular Dermal Matrix Used in Breast Implant Surgeries
Sponsor:
AlloSource
Organization:
AlloSource
Study Overview
Official Title:
Histological Analysis of AlloMend Acellular Dermal Matrix Used During the Initial Pre Pectoral Placement of Tissue Expanders for Breast Reconstruction and Evaluated at Time of Permanent Breast Implantation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
This is a prospective histologic analysis of biopsied tissue obtained from participants who have undergone a pre-pectoral breast reconstruction or augmentation surgery with expander placement and AlloMend Acellular Dermal Matrix
AlloMend Acellular Dermal Matrix graft incorporation with surrounding native soft tissue using histological assays characterizing host cell infiltration neovascularization inflammation and host replacement of ADM collagen will be studied
AlloMend Acellular Dermal Matrix graft incorporation with surrounding native soft tissue using histological assays characterizing host cell infiltration neovascularization inflammation and host replacement of ADM collagen will be studied
Detailed Description:
The purpose of this study is to evaluate the incorporation of AlloMend Acellular Dermal Matrix with native surrounding tissue by obtaining up to three 1 cm diameter biopsies per breast The samples will then be transported to AlloSource Research and Development Labs for slide preparation and histologic analysis
This study will be performed at one 1 clinical center in the United States
This study will be performed at one 1 clinical center in the United States
Study Oversight
Has Oversight DMC:
None
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?:
None