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

May 28, 2026 updated by: AbbVie

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

264

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center /ID# 268326
      • Orange, California, United States, 92868
        • Recruiting
        • University Of California Irvine Medical Center /ID# 267428
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford University Medical Center CTRU - 800 Welch Road /ID# 264196
      • Torrance, California, United States, 90505
        • Completed
        • South Bay Plastic Surgeons /ID# 264192
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University Of Colorado - Anschutz Medical Campus /ID# 268627
    • Florida
      • Brandon, Florida, United States, 33511
        • Not yet recruiting
        • Private Practice - Dr. Wayne Lee /ID# 281661
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida College of Medicine /ID# 267485
    • Illinois
      • Chicago, Illinois, United States, 60612-3841
        • Recruiting
        • Rush University Medical Center /ID# 275935
      • Northbrook, Illinois, United States, 60062
        • Recruiting
        • Endeavor Health - Health Center & Immediate Care - Northbrook /ID# 266302
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Hospital /ID# 265917
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University /ID# 264029
    • Nevada
      • Las Vegas, Nevada, United States, 89154
        • Recruiting
        • University of Nevada - Main Campus /ID# 264017
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • Recruiting
        • Rutgers New Jersey Medical School - Newark /ID# 264187
    • New York
      • Lake Success, New York, United States, 11042
        • Recruiting
        • Northwell Health Clinical Trials Office /ID# 268076
      • New York, New York, United States, 10016-6402
        • Completed
        • NYU Langone Medical Center /ID# 265621
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Atrium Health Wake Forest Baptist Medical Center /ID# 264382
    • Ohio
      • Columbus, Ohio, United States, 43212
        • Recruiting
        • Ohio State Havener Eye Institute - Columbus /ID# 266253
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Recruiting
        • Erlanger Health System /ID# 266608
      • Johnson City, Tennessee, United States, 37614
        • Recruiting
        • East Tennessee State University /ID# 264321
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas MD Anderson Cancer Center /ID# 264020
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Completed
        • University of Virginia /ID# 265098
    • Washington
      • Vancouver, Washington, United States, 98660
        • Recruiting
        • AG Aesthetic Center /ID# 264233

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acellular Dermal Matrix
Breast reconstruction with ARTIA Tissue Matrix.
Device: ARTIA Reconstructive Tissue Matrix
Surgical Implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of at Least One Major Complication related to Breast Reconstruction After Stage 1
Time Frame: Month 18
Number of participants with at least one major complication related to breast reconstruction.
Month 18
Number of Participants with Adverse Events (AEs)
Time Frame: Up to Approximately 36 Months
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a medical device which does not necessarily have a causal relationship with this treatment.
Up to Approximately 36 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in BREAST-Q Satisfaction with Breasts Score from Pre-Mastectomy After Stage 2
Time Frame: Up to Month 18
Participants evaluated satisfaction with their breasts using the BREAST-Q. Summary scores were computed by summing the score of each response and transferring them to a 0 (worst) to 100 (best) scale.
Up to Month 18
Occurrence of Capsular Contracture per Breast
Time Frame: Month 36
Number of participants with an occurrence of capsular contracture per breast.
Month 36
Occurrence of Reconstructive Failure Per Breast After Stage 1
Time Frame: Month 18
Number of participants with an occurrence of reconstructive failure per breast.
Month 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2024

Primary Completion (Estimated)

February 1, 2031

Study Completion (Estimated)

February 1, 2031

Study Registration Dates

First Submitted

August 26, 2024

First Submitted That Met QC Criteria

August 26, 2024

First Posted (Actual)

August 28, 2024

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • M24-708

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD Sharing Time Frame

For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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