Status:
RECRUITING
Evaluation of the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix Breast Reconstruction (ADORA) in Adult Participants
Lead Sponsor:
AbbVie
Conditions:
Breast Reconstruction
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- Participants who will undergo unilateral or bilateral mastectomy upon enrollment.
- Participants who are willing and able to undergo immediate pre-pectoral two-stage breast reconstruction with ARTIA or without ADM.
Exclusion
- Has an existing carcinoma of the breast without planned mastectomy or residual gross local tumor of the breast after mastectomy.
- Has any disease which is clinically known to impact wound healing ability, such as uncontrolled diabetes or history of compromised wound healing.
Key Trial Info
Start Date :
November 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
783 Patients enrolled
Trial Details
Trial ID
NCT06575192
Start Date
November 5 2024
End Date
December 1 2029
Last Update
December 26 2025
Active Locations (20)
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1
Cedars-Sinai Medical Center /ID# 268326
Los Angeles, California, United States, 90048
2
UC Irvine Medical Center /ID# 267428
Orange, California, United States, 92868-3201
3
Stanford University Medical Center CTRU - 800 Welch Road /ID# 264196
Palo Alto, California, United States, 94304
4
South Bay Plastic Surgeons /ID# 264192
Torrance, California, United States, 90505