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

NCT06575192 | Recruiting Phase 3 DMC FDA Device

• 1 other identifier: M24-708
• Study Type: interventional
• Target: 783
• Locations: 1 country
• Sites: 21

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

Keywords

Breast Reconstruction; ADORA; ARTIA

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  Up to 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.

  Up to Approximately 36 Months

Secondary Outcomes (1)

• Occurrence of Capsular Contracture per Breast

  Month 36

Study Arms (2)

Acellular Dermal Matrix

EXPERIMENTAL

Breast reconstruction with ARTIA Tissue Matrix.

Device: ARTIA Reconstructive Tissue Matrix

Non-Acellular Dermal Matrix (ADM) Control Group

OTHER

Breast reconstruction without ADM.

Other: No Intervention

Interventions

ARTIA Reconstructive Tissue Matrix DEVICE

Surgical Implant

Acellular Dermal Matrix

No Intervention OTHER

No ADM

Non-Acellular Dermal Matrix (ADM) Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (21)

Cedars-Sinai Medical Center /ID# 268326

Los Angeles, California, 90048, United States

RECRUITING

UC Irvine Medical Center /ID# 267428

Orange, California, 92868-3201, United States

RECRUITING

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

Palo Alto, California, 94304, United States

RECRUITING

South Bay Plastic Surgeons /ID# 264192

Torrance, California, 90505, United States

COMPLETED

University Of Colorado - Anschutz Medical Campus /ID# 268627

Aurora, Colorado, 80045, United States

RECRUITING

University of Florida College of Medicine /ID# 267485

Gainesville, Florida, 32610, United States

RECRUITING

Rush University Medical Center /ID# 275935

Chicago, Illinois, 60612-3841, United States

RECRUITING

Endeavor Health /ID# 266302

Northbrook, Illinois, 60062-2802, United States

RECRUITING

Johns Hopkins Hospital /ID# 265917

Baltimore, Maryland, 21287, United States

RECRUITING

Washington University School of Medicine - St. Louis /ID# 264029

St Louis, Missouri, 63130, United States

RECRUITING

University of Nevada - Main Campus /ID# 264017

Las Vegas, Nevada, 89154, United States

RECRUITING

Rutgers New Jersey Medical School - Newark /ID# 264187

Newark, New Jersey, 07103, United States

RECRUITING

Northwell Health Clinical Trials Office /ID# 268076

Lake Success, New York, 11042, United States

RECRUITING

NYU Langone Medical Center /ID# 265621

New York, New York, 10016-6402, United States

COMPLETED

Atrium Health Wake Forest Baptist Medical Center /ID# 264382

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Ohio State University Comprehensive Cancer Center /ID# 266253

Columbus, Ohio, 43202, United States

RECRUITING

Erlanger Health System /ID# 266608

Chattanooga, Tennessee, 37403, United States

RECRUITING

East Tennessee State University /ID# 264321

Johnson City, Tennessee, 37614, United States

RECRUITING

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

Houston, Texas, 77030, United States

RECRUITING

University of Virginia /ID# 265098

Charlottesville, Virginia, 22903, United States

RECRUITING

AG Aesthetic Center /ID# 264233

Vancouver, Washington, 98660, United States

RECRUITING

Related Links

• Related Info

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 28, 2024
• Study Start: November 5, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

US (21)