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

StatusRecruiting
PhasePhase 3
SponsorAbbVie
Started2024-11-05
View on ClinicalTrials.gov ↗
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.

Amendment history 5 changes detected by DataLookout

2026-06-02
Primary endpoint(s) modified
WasChange from Baseline in BREAST-Q Satisfaction with Breasts Score from Pre-Mastectomy After Stage 2, Number of Participants with Adverse Events (AEs), Occurrence of at Least One Major Complication related to Breast Reconstruction After Stage 1
NowNumber of Participants with Adverse Events (AEs), Occurrence of at Least One Major Complication related to Breast Reconstruction After Stage 1
2026-06-02
Enrollment reduced: 783 → 264 participants
2026-06-02
Trial arms changed: 2 → 1
2026-06-02
Primary completion pushed: 2029-12 → 2031-02
2026-06-02
Completion pushed: 2029-12 → 2031-02
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 2026-08-06