Actively Recruiting
Evaluation of ARTIA Reconstructive Tissue Matrix in Two-Stage Implant-Based Breast Reconstruction Post-Mastectomy
Led by AbbVie · Updated on 2026-06-01
264
Participants Needed
22
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of ARTIA Reconstructive Tissue Matrix in adults undergoing immediate, two-stage, implant-based breast reconstruction after mastectomy. This Phase 3 pivotal study focuses on adult female participants who require breast reconstruction following mastectomy procedures. The study aims to assess how well ARTIA works and its safety profile in this specific surgical context. Participants will receive breast reconstruction using the ARTIA Tissue Matrix device in a two-stage, prepectoral implant-based procedure following mastectomy. The study is open-label and non-randomized, conducted across multiple centers. This intervention involves surgical implant placement designed to support the reconstruction process. The treatment timeline includes follow-up assessments up to approximately 36 months. During the study, participants will be monitored for major complications related to breast reconstruction after the first surgical stage at 18 months, as well as adverse events up to about 36 months. Secondary measures include reconstructive failure rates per breast, changes in breast satisfaction scores after the second stage, and occurrence of capsular contracture up to 36 months. Regular evaluations and safety monitoring will help determine the outcomes of ARTIA use in this population.
CONDITIONS
Brief Title
Evaluation of the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix Breast Reconstruction (ADORA) in Adult Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants planning to have unilateral or bilateral mastectomy at enrollment
- Willing and able to undergo immediate prepectoral, implant-based, two-stage breast reconstruction with ARTIA
You will not qualify if you...
- Existing breast carcinoma without planned mastectomy or residual gross local tumor after mastectomy
- Any disease known to impair wound healing, 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 months
Participants undergo mastectomy followed by immediate breast reconstruction using the ARTIA Reconstructive Tissue Matrix implant.
Approximately 6 post-operative visits
Duration - Up to 36 months
Participants are monitored for safety and effectiveness outcomes including complications, reconstructive failure, and satisfaction with breast reconstruction.
Regular follow-up visits over the monitoring period
Trial Site Locations
Total: 22 locations
1
Cedars-Sinai Medical Center /ID# 268326
Los Angeles, California, United States, 90048
Actively Recruiting
2
University Of California Irvine Medical Center /ID# 267428
Orange, California, United States, 92868
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
Private Practice - Dr. Wayne Lee /ID# 281661
Brandon, Florida, United States, 33511
Not Yet Recruiting
7
University of Florida College of Medicine /ID# 267485
Gainesville, Florida, United States, 32610
Actively Recruiting
8
Rush University Medical Center /ID# 275935
Chicago, Illinois, United States, 60612-3841
Actively Recruiting
9
Endeavor Health - Health Center & Immediate Care - Northbrook /ID# 266302
Northbrook, Illinois, United States, 60062
Actively Recruiting
10
Johns Hopkins Hospital /ID# 265917
Baltimore, Maryland, United States, 21287
Actively Recruiting
11
Washington University /ID# 264029
St Louis, Missouri, United States, 63110
Actively Recruiting
12
University of Nevada - Main Campus /ID# 264017
Las Vegas, Nevada, United States, 89154
Actively Recruiting
13
Rutgers New Jersey Medical School - Newark /ID# 264187
Newark, New Jersey, United States, 07103
Actively Recruiting
14
Northwell Health Clinical Trials Office /ID# 268076
Lake Success, New York, United States, 11042
Actively Recruiting
15
NYU Langone Medical Center /ID# 265621
New York, New York, United States, 10016-6402
Completed
16
Atrium Health Wake Forest Baptist Medical Center /ID# 264382
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
17
Ohio State Havener Eye Institute - Columbus /ID# 266253
Columbus, Ohio, United States, 43212
Actively Recruiting
18
Erlanger Health System /ID# 266608
Chattanooga, Tennessee, United States, 37403
Actively Recruiting
19
East Tennessee State University /ID# 264321
Johnson City, Tennessee, United States, 37614
Actively Recruiting
20
The University of Texas MD Anderson Cancer Center /ID# 264020
Houston, Texas, United States, 77030
Actively Recruiting
21
University of Virginia /ID# 265098
Charlottesville, Virginia, United States, 22903
Completed
22
AG Aesthetic Center /ID# 264233
Vancouver, Washington, United States, 98660
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here