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

RecruitingPhase 3

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

Who can join

Ages 18 and older · Women

Full eligibility criteria

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.

About the study

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.

What is being tested

ARTIA Reconstructive Tissue Matrix (device)

Sponsor: AbbVie · Participants: 264 · Started: Nov 5, 2024

Contact the study team

ABBVIE CALL CENTER · Phone: 844-663-3742

Official record on ClinicalTrials.gov — NCT06575192

Locations in the U.S.

California	Cedars-Sinai Medical Center /ID# 268326, Los Angeles University Of California Irvine Medical Center /ID# 267428, Orange Stanford University Medical Center CTRU - 800 Welch Road /ID# 264196, Palo Alto
Colorado	University Of Colorado - Anschutz Medical Campus /ID# 268627, Aurora
Florida	Private Practice - Dr. Wayne Lee /ID# 281661, Brandon (Not yet recruiting) University of Florida College of Medicine /ID# 267485, Gainesville
Illinois	Rush University Medical Center /ID# 275935, Chicago Endeavor Health - Health Center & Immediate Care - Northbrook /ID# 266302, Northbrook
Maryland	Johns Hopkins Hospital /ID# 265917, Baltimore
Missouri	Washington University /ID# 264029, St Louis
New Jersey	Rutgers New Jersey Medical School - Newark /ID# 264187, Newark
North Carolina	Atrium Health Wake Forest Baptist Medical Center /ID# 264382, Winston-Salem
Ohio	Ohio State Havener Eye Institute - Columbus /ID# 266253, Columbus
Tennessee	Erlanger Health System /ID# 266608, Chattanooga East Tennessee State University /ID# 264321, Johnson City
Texas	The University of Texas MD Anderson Cancer Center /ID# 264020, Houston
Utah	The Plastics Clinic and Spa /ID# 281483, Draper (Not yet recruiting)

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.