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NCT06575192PHASE3Recruiting

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

AbbVie

Start Date

11/5/2024

Completion Date

2/1/2031

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 Criteria

Age Range: 18 years to No maximum

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.

Interventions

DEVICE

ARTIA Reconstructive Tissue Matrix

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Conditions

Breast Reconstruction

Locations

Cedars-Sinai Medical Center /ID# 268326

Los Angeles, California 90048

United States

University Of California Irvine Medical Center /ID# 267428

Orange, California 92868

United States

Stanford University Medical Center CTRU - 800 Welch Road /ID# 264196

Palo Alto, California 94304

United States

South Bay Plastic Surgeons /ID# 264192

Torrance, California 90505

United States

University Of Colorado - Anschutz Medical Campus /ID# 268627

Aurora, Colorado 80045

United States

Private Practice - Dr. Wayne Lee /ID# 281661

Brandon, Florida 33511

United States

University of Florida College of Medicine /ID# 267485

Gainesville, Florida 32610

United States

Rush University Medical Center /ID# 275935

Chicago, Illinois 60612-3841

United States

Endeavor Health - Health Center & Immediate Care - Northbrook /ID# 266302

Northbrook, Illinois 60062

United States

Johns Hopkins Hospital /ID# 265917

Baltimore, Maryland 21287

United States

Washington University /ID# 264029

St Louis, Missouri 63110

United States

University of Nevada - Main Campus /ID# 264017

Las Vegas, Nevada 89154

United States

Rutgers New Jersey Medical School - Newark /ID# 264187

Newark, New Jersey 07103

United States

Northwell Health Clinical Trials Office /ID# 268076

Lake Success, New York 11042

United States

NYU Langone Medical Center /ID# 265621

New York, New York 10016-6402

United States

Atrium Health Wake Forest Baptist Medical Center /ID# 264382

Winston-Salem, North Carolina 27157

United States

Ohio State Havener Eye Institute - Columbus /ID# 266253

Columbus, Ohio 43212

United States

Erlanger Health System /ID# 266608

Chattanooga, Tennessee 37403

United States

East Tennessee State University /ID# 264321

Johnson City, Tennessee 37614

United States

The University of Texas MD Anderson Cancer Center /ID# 264020

Houston, Texas 77030

United States

The Plastics Clinic and Spa /ID# 281483

Draper, Utah 84020

United States

University of Virginia /ID# 265098

Charlottesville, Virginia 22903

United States

AG Aesthetic Center /ID# 264233

Vancouver, Washington 98660

United States