Clinical trial NCT06575192: Evaluation of the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix Breast Reconstruction (ADORA) in Adult Participants
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Breast Reconstruction
Keywords: Breast Reconstruction
ADORA
ARTIA
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-08-28
Enrollment: 783
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Occurrence of at Least One Major Complication related to Breast Reconstruction After Stage 1
timeFrame: Month 18
measure: Change from Baseline in BREAST-Q Satisfaction with Breasts Score from Pre-Mastectomy After Stage 2
timeFrame: Up to Month 18
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to Approximately 36 Months
Secondary outcomes:
measure: Occurrence of Capsular Contracture per Breast
timeFrame: Month 36
Other outcomes:
Locations:
city: Orange
country: United States
facility: UC Irvine Medical Center /ID# 267428
state: California
city: Torrance
country: United States
facility: South Bay Plastic Surgeons /ID# 264192
state: California
city: Gainesville
country: United States
facility: University of Florida College of Medicine /ID# 267485
state: Florida
city: Northbrook
country: United States
facility: Endeavor Health /ID# 266302
state: Illinois
city: Saint Louis
country: United States
facility: Washington University School of Medicine - St. Louis /ID# 264029
state: Missouri
city: Las Vegas
country: United States
facility: University of Nevada - Main Campus /ID# 264017
state: Nevada
city: Newark
country: United States
facility: Rutgers New Jersey Medical School - Newark /ID# 264187
state: New Jersey
city: New York
country: United States
facility: NYU Langone Medical Center /ID# 265621
state: New York
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center /ID# 266253
state: Ohio
city: Chattanooga
country: United States
facility: Erlanger Health System /ID# 266608
state: Tennessee
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center /ID# 264020
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia /ID# 265098
state: Virginia
city: Vancouver
country: United States
facility: AG Aesthetic Center /ID# 264233
state: Washington
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: