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

Phase 3

Recruiting

• Conditions: Breast Reconstruction
• Interventions: Device: ARTIA Reconstructive Tissue Matrix; Other: No Intervention

• Registration Number: NCT06575192
• Lead Sponsor: AbbVie

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-26
• Study First Submitted QC: 2024-08-26
• Study First Posted: 2024-08-28
• Study Start: 2024-11-05
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-20
• Primary Completion: 2029-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 783

Inclusion Criteria

• 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.

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acellular Dermal Matrix	ARTIA Reconstructive Tissue Matrix	Breast reconstruction with ARTIA Tissue Matrix.
Non-Acellular Dermal Matrix (ADM) Control Group	No Intervention	Breast reconstruction without ADM.

Primary Outcome Measures

Name	Time	Method
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.
Occurrence of at Least One Major Complication related to Breast Reconstruction After Stage 1	Month 18	Number of participants with at least one major complication related to breast reconstruction.
Change from Baseline in BREAST-Q Satisfaction with Breasts Score from Pre-Mastectomy After Stage 2	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.

Secondary Outcome Measures

Name	Time	Method
Occurrence of Capsular Contracture per Breast	Month 36	Number of participants with an occurrence of capsular contracture per breast.

Trial Locations

Locations (12)

UC Irvine Medical Center /ID# 267428; 🇺🇸 Orange, California, United States

South Bay Plastic Surgeons /ID# 264192; 🇺🇸 Torrance, California, United States

Endeavor Health /ID# 266302; 🇺🇸 Northbrook, Illinois, United States

Washington University School of Medicine - St. Louis /ID# 264029; 🇺🇸 Saint Louis, Missouri, United States

University of Nevada - Main Campus /ID# 264017; 🇺🇸 Las Vegas, Nevada, United States

Rutgers New Jersey Medical School - Newark /ID# 264187; 🇺🇸 Newark, New Jersey, United States

NYU Langone Medical Center /ID# 265621; 🇺🇸 New York, New York, United States

Ohio State University Comprehensive Cancer Center /ID# 266253; 🇺🇸 Columbus, Ohio, United States

Erlanger Health System /ID# 266608; 🇺🇸 Chattanooga, Tennessee, United States

The University of Texas MD Anderson Cancer Center /ID# 264020; 🇺🇸 Houston, Texas, United States

University of Virginia /ID# 265098; 🇺🇸 Charlottesville, Virginia, United States

AG Aesthetic Center /ID# 264233; 🇺🇸 Vancouver, Washington, United States