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

Last updated: February 23, 2026
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

3

Condition

Breast Reconstruction

Treatment

ARTIA Reconstructive Tissue Matrix

No Intervention

Clinical Study ID

NCT06575192
M24-708
  • Ages > 18
  • Female

Study 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

Inclusion

Inclusion Criteria:

  • Participants who will undergo unilateral or bilateral mastectomy upon enrollment.

  • Participants who are willing and able to undergo immediate pre-pectoral two-stagebreast reconstruction with ARTIA or without ADM.

Exclusion

Exclusion Criteria:

  • Has an existing carcinoma of the breast without planned mastectomy or residual grosslocal tumor of the breast after mastectomy.

  • Has any disease which is clinically known to impact wound healing ability, such asuncontrolled diabetes or history of compromised wound healing.

Study Design

Total Participants: 783
Treatment Group(s): 2
Primary Treatment: ARTIA Reconstructive Tissue Matrix
Phase: 3
Study Start date:
November 05, 2024
Estimated Completion Date:
December 31, 2029

Connect with a study center

  • UC Irvine Medical Center /ID# 267428

    Orange, California 92868-3201
    United States

    Site Not Available

  • South Bay Plastic Surgeons /ID# 264192

    Torrance, California 90505-3927
    United States

    Site Not Available

  • Cedars-Sinai Medical Center /ID# 268326

    Los Angeles 5368361, California 5332921 90048
    United States

    Active - Recruiting

  • UC Irvine Medical Center /ID# 267428

    Orange 5379513, California 5332921 92868-3201
    United States

    Active - Recruiting

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

    Palo Alto 5380748, California 5332921 94304
    United States

    Active - Recruiting

  • South Bay Plastic Surgeons /ID# 264192

    Torrance 5403022, California 5332921 90505
    United States

    Completed

  • University Of Colorado - Anschutz Medical Campus /ID# 268627

    Aurora 5412347, Colorado 5417618 80045
    United States

    Active - Recruiting

  • University of Florida College of Medicine /ID# 267485

    Gainesville, Florida 32610
    United States

    Site Not Available

  • University of Florida College of Medicine /ID# 267485

    Gainesville 4156404, Florida 4155751 32610
    United States

    Active - Recruiting

  • Endeavor Health /ID# 266302

    Northbrook, Illinois 60062-2802
    United States

    Site Not Available

  • Rush University Medical Center /ID# 275935

    Chicago 4887398, Illinois 4896861 60612-3841
    United States

    Active - Recruiting

  • Endeavor Health /ID# 266302

    Northbrook 4904056, Illinois 4896861 60062-2802
    United States

    Active - Recruiting

  • Johns Hopkins Hospital /ID# 265917

    Baltimore 4347778, Maryland 4361885 21287
    United States

    Active - Recruiting

  • Washington University School of Medicine - St. Louis /ID# 264029

    Saint Louis, Missouri 63130
    United States

    Site Not Available

  • Washington University School of Medicine - St. Louis /ID# 264029

    St Louis 4407066, Missouri 4398678 63130
    United States

    Active - Recruiting

  • University of Nevada - Main Campus /ID# 264017

    Las Vegas, Nevada 89154
    United States

    Site Not Available

  • University of Nevada - Main Campus /ID# 264017

    Las Vegas 5506956, Nevada 5509151 89154
    United States

    Active - Recruiting

  • Rutgers New Jersey Medical School - Newark /ID# 264187

    Newark, New Jersey 07103
    United States

    Site Not Available

  • Rutgers New Jersey Medical School - Newark /ID# 264187

    Newark 5101798, New Jersey 5101760 07103
    United States

    Active - Recruiting

  • NYU Langone Medical Center /ID# 265621

    New York, New York 10016-6402
    United States

    Site Not Available

  • Northwell Health Clinical Trials Office /ID# 268076

    Lake Success 5123853, New York 5128638 11042
    United States

    Active - Recruiting

  • NYU Langone Medical Center /ID# 265621

    New York 5128581, New York 5128638 10016-6402
    United States

    Completed

  • Atrium Health Wake Forest Baptist Medical Center /ID# 264382

    Winston-Salem 4499612, North Carolina 4482348 27157
    United States

    Active - Recruiting

  • Ohio State University Comprehensive Cancer Center /ID# 266253

    Columbus, Ohio 43202
    United States

    Site Not Available

  • Ohio State University Comprehensive Cancer Center /ID# 266253

    Columbus 4509177, Ohio 5165418 43202
    United States

    Active - Recruiting

  • Erlanger Health System /ID# 266608

    Chattanooga, Tennessee 37403
    United States

    Site Not Available

  • Erlanger Health System /ID# 266608

    Chattanooga 4612862, Tennessee 4662168 37403
    United States

    Active - Recruiting

  • East Tennessee State University /ID# 264321

    Johnson City 4633419, Tennessee 4662168 37614
    United States

    Active - Recruiting

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

    Houston, Texas 77030
    United States

    Site Not Available

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

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • University of Virginia /ID# 265098

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • University of Virginia /ID# 265098

    Charlottesville 4752031, Virginia 6254928 22903
    United States

    Active - Recruiting

  • AG Aesthetic Center /ID# 264233

    Vancouver, Washington 98660
    United States

    Site Not Available

  • AG Aesthetic Center /ID# 264233

    Vancouver 5814616, Washington 5815135 98660
    United States

    Active - Recruiting

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