An official website of the United States government
Evaluation of the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix Breast Reconstruction (ADORA) in Adult Participants
Trial Status: active
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.
Inclusion Criteria
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 Criteria
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.
Additional locations may be listed on ClinicalTrials.gov for NCT06575192.
