Actively Recruiting

Phase 3
Age: 18Years +
FEMALE
NCT06575192

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

Led by AbbVie · Updated on 2026-02-24

783

Participants Needed

21

Research Sites

264 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants who will undergo unilateral or bilateral mastectomy upon enrollment.
  • Participants who are willing and able to undergo immediate pre-pectoral two-stage breast reconstruction with ARTIA or without ADM.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 21 locations

1

Cedars-Sinai Medical Center /ID# 268326

Los Angeles, California, United States, 90048

Actively Recruiting

2

UC Irvine Medical Center /ID# 267428

Orange, California, United States, 92868-3201

Actively Recruiting

3

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

Palo Alto, California, United States, 94304

Actively Recruiting

4

South Bay Plastic Surgeons /ID# 264192

Torrance, California, United States, 90505

Completed

5

University Of Colorado - Anschutz Medical Campus /ID# 268627

Aurora, Colorado, United States, 80045

Actively Recruiting

6

University of Florida College of Medicine /ID# 267485

Gainesville, Florida, United States, 32610

Actively Recruiting

7

Rush University Medical Center /ID# 275935

Chicago, Illinois, United States, 60612-3841

Actively Recruiting

8

Endeavor Health /ID# 266302

Northbrook, Illinois, United States, 60062-2802

Actively Recruiting

9

Johns Hopkins Hospital /ID# 265917

Baltimore, Maryland, United States, 21287

Actively Recruiting

10

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

St Louis, Missouri, United States, 63130

Actively Recruiting

11

University of Nevada - Main Campus /ID# 264017

Las Vegas, Nevada, United States, 89154

Actively Recruiting

12

Rutgers New Jersey Medical School - Newark /ID# 264187

Newark, New Jersey, United States, 07103

Actively Recruiting

13

Northwell Health Clinical Trials Office /ID# 268076

Lake Success, New York, United States, 11042

Actively Recruiting

14

NYU Langone Medical Center /ID# 265621

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

Completed

15

Atrium Health Wake Forest Baptist Medical Center /ID# 264382

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

16

Ohio State University Comprehensive Cancer Center /ID# 266253

Columbus, Ohio, United States, 43202

Actively Recruiting

17

Erlanger Health System /ID# 266608

Chattanooga, Tennessee, United States, 37403

Actively Recruiting

18

East Tennessee State University /ID# 264321

Johnson City, Tennessee, United States, 37614

Actively Recruiting

19

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

Houston, Texas, United States, 77030

Actively Recruiting

20

University of Virginia /ID# 265098

Charlottesville, Virginia, United States, 22903

Actively Recruiting

21

AG Aesthetic Center /ID# 264233

Vancouver, Washington, United States, 98660

Actively Recruiting

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Research Team

A

ABBVIE CALL CENTER

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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