RecruitingPhase 3NCT06575192
Evaluation of the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix Breast Reconstruction (ADORA) in Adult Participants
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
Sponsor
AbbVie
Enrollment
783 participants
Start Date
Nov 5, 2024
Study Type
INTERVENTIONAL
Conditions
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
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria2
- 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 Criteria2
- 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.
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Interventions
DEVICEARTIA Reconstructive Tissue Matrix
Surgical Implant
OTHERNo Intervention
No ADM
Locations(21)
View Full Details on ClinicalTrials.gov
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NCT06575192
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