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Evaluation of the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix Breast Reconstruction (ADORA) in Adult Participants
Sponsor: AbbVie
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.
Official title: 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
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
783
Start Date
2024-11-05
Completion Date
2029-12
Last Updated
2026-02-24
Healthy Volunteers
No
Conditions
Interventions
ARTIA Reconstructive Tissue Matrix
Surgical Implant
No Intervention
No ADM
Locations (21)
Cedars-Sinai Medical Center /ID# 268326
Los Angeles, California, United States
UC Irvine Medical Center /ID# 267428
Orange, California, United States
Stanford University Medical Center CTRU - 800 Welch Road /ID# 264196
Palo Alto, California, United States
South Bay Plastic Surgeons /ID# 264192
Torrance, California, United States
University Of Colorado - Anschutz Medical Campus /ID# 268627
Aurora, Colorado, United States
University of Florida College of Medicine /ID# 267485
Gainesville, Florida, United States
Rush University Medical Center /ID# 275935
Chicago, Illinois, United States
Endeavor Health /ID# 266302
Northbrook, Illinois, United States
Johns Hopkins Hospital /ID# 265917
Baltimore, Maryland, United States
Washington University School of Medicine - St. Louis /ID# 264029
St Louis, Missouri, United States
University of Nevada - Main Campus /ID# 264017
Las Vegas, Nevada, United States
Rutgers New Jersey Medical School - Newark /ID# 264187
Newark, New Jersey, United States
Northwell Health Clinical Trials Office /ID# 268076
Lake Success, New York, United States
NYU Langone Medical Center /ID# 265621
New York, New York, United States
Atrium Health Wake Forest Baptist Medical Center /ID# 264382
Winston-Salem, North Carolina, United States
Ohio State University Comprehensive Cancer Center /ID# 266253
Columbus, Ohio, United States
Erlanger Health System /ID# 266608
Chattanooga, Tennessee, United States
East Tennessee State University /ID# 264321
Johnson City, Tennessee, United States
The University of Texas MD Anderson Cancer Center /ID# 264020
Houston, Texas, United States
University of Virginia /ID# 265098
Charlottesville, Virginia, United States
AG Aesthetic Center /ID# 264233
Vancouver, Washington, United States