Breast ReconstructionPhase 3NCT06575192
Evaluation of the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix Breast Reconstruction (ADORA) in Adult Participants
A Phase 3 study testing ARTIA Reconstructive Tissue Matrix in people with Breast Reconstruction, run by AbbVie at 23 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Reconstruction
- What is being tested?
- ARTIA Reconstructive Tissue Matrix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 23 sitesUnited States
- Study dates
- 5 Nov 2024to Feb 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
23 sites in 1 country. Contact the study team or a site near you to ask about taking part.
23 sites in 1 country
United States23 sites, 17 recruiting
- Recruiting
University Of Colorado - Anschutz Medical Campus /ID# 268627
Aurora, Colorado, 80045
- Recruiting
Johns Hopkins Hospital /ID# 265917
Baltimore, Maryland, 21287
- Not yet recruiting
Private Practice - Dr. Wayne Lee /ID# 281661
Brandon, Florida, 33511
- Completed
University of Virginia /ID# 265098
Charlottesville, Virginia, 22903
- Recruiting
Erlanger Health System /ID# 266608
Chattanooga, Tennessee, 37403
- Recruiting
Rush University Medical Center /ID# 275935
Chicago, Illinois, 60612-3841
- Recruiting
Ohio State Havener Eye Institute - Columbus /ID# 266253
Columbus, Ohio, 43212
- Not yet recruiting
The Plastics Clinic and Spa /ID# 281483
Draper, Utah, 84020
- Recruiting
University of Florida College of Medicine /ID# 267485
Gainesville, Florida, 32610
- Recruiting
The University of Texas MD Anderson Cancer Center /ID# 264020
Houston, Texas, 77030
- Recruiting
East Tennessee State University /ID# 264321
Johnson City, Tennessee, 37614
- Completed
Northwell Health Clinical Trials Office /ID# 268076
Lake Success, New York, 11042
- Completed
University of Nevada - Main Campus /ID# 264017
Las Vegas, Nevada, 89154
- Recruiting
Cedars-Sinai Medical Center /ID# 268326
Los Angeles, California, 90048
- Completed
NYU Langone Medical Center /ID# 265621
New York, New York, 10016-6402
- Recruiting
Rutgers New Jersey Medical School - Newark /ID# 264187
Newark, New Jersey, 07103
- Recruiting
Endeavor Health - Health Center & Immediate Care - Northbrook /ID# 266302
Northbrook, Illinois, 60062
- Recruiting
University Of California Irvine Medical Center /ID# 267428
Orange, California, 92868
- Recruiting
Stanford University Medical Center CTRU - 800 Welch Road /ID# 264196
Palo Alto, California, 94304
- Recruiting
Washington University /ID# 264029
St Louis, Missouri, 63110
- Completed
South Bay Plastic Surgeons /ID# 264192
Torrance, California, 90505
- Completed
AG Aesthetic Center /ID# 264233
Vancouver, Washington, 98660
- Recruiting
Atrium Health Wake Forest Baptist Medical Center /ID# 264382
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
- Conditions
- Breast Reconstruction
- Being tested
- ARTIA Reconstructive Tissue Matrix
- Keywords
- Breast Reconstruction, ADORA, ARTIA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARTIA Reconstructive Tissue MatrixDevice
Surgical Implant
| Study group | Role | What they receive |
|---|---|---|
| Acellular Dermal Matrix | Experimental | Breast reconstruction with ARTIA Tissue Matrix. Receives: Device: ARTIA Reconstructive Tissue Matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of at Least One Major Complication related to Breast Reconstruction After Stage 1
Number of participants with at least one major complication related to breast reconstruction.
Measured: Month 18
Number of Participants with Adverse Events (AEs)
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.
Measured: Up to Approximately 36 Months
Secondary outcomes (3)
Occurrence of Reconstructive Failure Per Breast After Stage 1
Number of participants with an occurrence of reconstructive failure per breast.
Measured: Month 18
Change from Baseline in BREAST-Q Satisfaction with Breasts Score from Pre-Mastectomy After Stage 2
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.
Measured: Up to Month 18
Occurrence of Capsular Contracture per Breast
Number of participants with an occurrence of capsular contracture per breast.
Measured: Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start5 Nov 2024
- Primary completionFeb 2031 (estimated)
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ReconstructionStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06575192
- Sponsor's protocol ID
- M24-708
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2024
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06575192
- Acronym / sponsor ID
- M24-708
- Conditions
- Breast Reconstruction
- Keywords
- Breast Reconstruction, ADORA, ARTIA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- Feb 2031 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acellular Dermal Matrix | Experimental | Device: ARTIA Reconstructive Tissue MatrixBreast reconstruction with ARTIA Tissue Matrix. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARTIA Reconstructive Tissue MatrixSurgical Implant | Device | Acellular Dermal Matrix |
Primary outcome
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.
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.
3 secondary outcomes
Occurrence of Reconstructive Failure Per Breast After Stage 1
Time frame: Month 18
Change from Baseline in BREAST-Q Satisfaction with Breasts Score from Pre-Mastectomy After Stage 2
Time frame: Up to Month 18
Occurrence of Capsular Contracture per Breast
Time frame: Month 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ABBVIE INC. study director
AbbVie
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ARTIA Reconstructive Tissue Matrix in people with Breast Reconstruction, run by AbbVie at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of at Least One Major Complication related to Breast Reconstruction After Stage 1 (time frame: Month 18). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.