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

RecruitingPhase 3Ages 18 Years - anyFemaleAbbVie
NCT06575192 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Participants who will undergo unilateral or bilateral mastectomy upon enrollment. * Participants who are willing and able to undergo immediate prepectoral, implant based, two-stage breast reconstruction with ARTIA. 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.
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What it tests

  • ARTIA Reconstructive Tissue Matrix
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Where

23 sites
Cedars-Sinai Medical Center /ID# 268326
Los Angeles, United States
University Of California Irvine Medical Center /ID# 267428
Orange, United States
Stanford University Medical Center CTRU - 800 Welch Road /ID# 264196
Palo Alto, United States
South Bay Plastic Surgeons /ID# 264192
Torrance, United States
University Of Colorado - Anschutz Medical Campus /ID# 268627
Aurora, United States
Private Practice - Dr. Wayne Lee /ID# 281661
Brandon, United States
University of Florida College of Medicine /ID# 267485
Gainesville, United States
Rush University Medical Center /ID# 275935
Chicago, United States

…and 15 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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