Recruiting

Phase 3

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

Sponsor:

AbbVie

Code:

NCT06575192

Conditions

Breast Reconstruction

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ARTIA Reconstructive Tissue Matrix

Study Details

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.

Conditions

Breast Reconstruction

Study ID

NCT06575192

Start date

Nov 5, 2024

Status verified date

Aug, 2026

Completion date

Feb, 2031

Anticipated

Primary completion date

Feb, 2031

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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 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

Enrollment

264 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Acellular Dermal Matrix

Breast reconstruction with ARTIA Tissue Matrix.

Interventions

ARTIA Reconstructive Tissue Matrix

Surgical Implant

Primary outcome measure

Occurrence of at Least One Major Complication related to Breast Reconstruction After Stage 1 [ Time Frame: Month 18 ]
Number of Participants with Adverse Events (AEs) [ Time Frame: Up to Approximately 36 Months ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742 abbvieclinicaltrials@abbvie.com

Locations

Cedars-Sinai Medical Center /ID# 268326

Recruiting

Los Angeles, California, United States, 90048

University Of California Irvine Medical Center /ID# 267428

Recruiting

Orange, California, United States, 92868

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

Recruiting

Palo Alto, California, United States, 94304

University Of Colorado - Anschutz Medical Campus /ID# 268627

Recruiting

Aurora, Colorado, United States, 80045

University of Florida College of Medicine /ID# 267485

Recruiting

Gainesville, Florida, United States, 32610

Rush University Medical Center /ID# 275935

Recruiting

Chicago, Illinois, United States, 60612-3841

Endeavor Health - Health Center & Immediate Care - Northbrook /ID# 266302

Recruiting

Northbrook, Illinois, United States, 60062

Johns Hopkins Hospital /ID# 265917

Recruiting

Baltimore, Maryland, United States, 21287

Washington University /ID# 264029

Recruiting

St Louis, Missouri, United States, 63110

Rutgers New Jersey Medical School - Newark /ID# 264187

Recruiting

Newark, New Jersey, United States, 07103

Atrium Health Wake Forest Baptist Medical Center /ID# 264382

Recruiting

Winston-Salem, North Carolina, United States, 27157

Ohio State Havener Eye Institute - Columbus /ID# 266253

Recruiting

Columbus, Ohio, United States, 43212

Erlanger Health System /ID# 266608

Recruiting

Chattanooga, Tennessee, United States, 37403

East Tennessee State University /ID# 264321

Recruiting

Johnson City, Tennessee, United States, 37614

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

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

AbbVie

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

Breast Reconstruction
ADORA
ARTIA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AbbVie on 2026-08-06.