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ARTIA Reconstructive Tissue Matrix for Breast Reconstruction

This study is looking at the safety and effectiveness of ARTIA Reconstructive Tissue Matrix, a surgical implant, for women having breast reconstruction right after a mastectomy (surgery to remove a breast). You may be able to join if you are an adult woman having a mastectomy and are willing to have immediate, two-stage, implant-based breast reconstruction using ARTIA. The study will measure how many participants have major complications related to breast reconstruction after 18 months and track any side effects for up to about 36 months. The current recruitment status is unclear, and the study plans to enroll 264 participants.

Study design
This interventional study plans to enroll 264 adult women. It is evaluating a surgical implant called ARTIA Reconstructive Tissue Matrix.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for major complications related to breast reconstruction for 18 months, and for adverse events (side effects) for up to approximately 36 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06575192

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
AbbVie
~264 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:ARTIA Reconstructive Tissue Matrix

At a glance

Recruiting sites
15 of 23 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurrence of at Least One Major Complication related to Breast Reconstruction After Stage 1
Measured over Month 18
+1 more outcome measured

Conditions

Breast Reconstruction

Explore related trials

Mammoplasty

Where it's being run

23 sites across 16 states
California4
Florida2
Illinois2
New York2
Tennessee2
Colorado1
Maryland1
Missouri1

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

ABBVIE CALL CENTER
[email protected]
844-663-3742
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Occurrence of at Least One Major Complication related to Breast Reconstruction After Stage 1Month 18

    Number of participants with at least one major complication related to breast reconstruction.

  • Number of Participants with Adverse Events (AEs)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.