Clinical Trial

Evaluation of the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix Breast Reconstruction (ADORA) in Adult Participants

Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 5 changes
critical Primary endpoint(s) modified 2026-06-02
notable Enrollment reduced: 783 -> 264 participants 2026-06-02
minor Trial arms changed: 2 -> 1 2026-06-02
notable Primary completion pushed: 2029-12 -> 2031-02 2026-06-02
minor Completion pushed: 2029-12 -> 2031-02 2026-06-02
Trial Details
NCT Number NCT06575192
Lead Sponsor AbbVie
Conditions Breast Reconstruction
Enrollment 264 participants
Start Date 2024-11-05
Primary Completion 2031-02 (estimated)
Study Completion 2031-02 (estimated)
Updated on ClinicalTrials.gov 2026-07-14