Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2025-12-24 @ 3:29 PM
Study NCT ID:
NCT06575192
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2024-08-26
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix Breast Reconstruction (ADORA) in Adult Participants
Sponsor:
AbbVie
Organization:
Study Overview
Official Title:
A Prospective, Multicenter, Open-Label, Non-Randomized, Controlled Pivotal Study to Evaluate the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix in Implant-Based Two Stage Prepectoral Breast Reconstruction Post-Mastectomy
Status:
RECRUITING
Status Verified Date:
2025-12
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:
The purpose of this study is to evaluate the safety and effectiveness of ARTIA in adult participants undergoing immediate, two-stage, implant-based breast reconstruction post-mastectomy.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: