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

NCT06575192 · tracked via the Priya Life Science USA tracker

Sponsor

AbbVie

Phase

Phase 3

Started

2024-11-05

Last updated

2026-08-06

Condition(s) studied

Breast Reconstruction

Investigational drug(s) / intervention(s)

ARTIA Reconstructive Tissue Matrix

ARTIA Reconstructive Tissue Matrix: Surgical Implant

Study 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

Sex

FEMALE

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

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.
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.

Trial sites (23)

Facility	City	Region	Status
Cedars-Sinai Medical Center /ID# 268326	Los Angeles	California	Recruiting
University Of California Irvine Medical Center /ID# 267428	Orange	California	Recruiting
Stanford University Medical Center CTRU - 800 Welch Road /ID# 264196	Palo Alto	California	Recruiting
South Bay Plastic Surgeons /ID# 264192	Torrance	California	Completed
University Of Colorado - Anschutz Medical Campus /ID# 268627	Aurora	Colorado	Recruiting
Private Practice - Dr. Wayne Lee /ID# 281661	Brandon	Florida	Not Yet Recruiting
University of Florida College of Medicine /ID# 267485	Gainesville	Florida	Recruiting
Rush University Medical Center /ID# 275935	Chicago	Illinois	Recruiting
Endeavor Health - Health Center & Immediate Care - Northbrook /ID# 266302	Northbrook	Illinois	Recruiting
Johns Hopkins Hospital /ID# 265917	Baltimore	Maryland	Recruiting
Washington University /ID# 264029	St Louis	Missouri	Recruiting
University of Nevada - Main Campus /ID# 264017	Las Vegas	Nevada	Completed
Rutgers New Jersey Medical School - Newark /ID# 264187	Newark	New Jersey	Recruiting
Northwell Health Clinical Trials Office /ID# 268076	Lake Success	New York	Completed
NYU Langone Medical Center /ID# 265621	New York	New York	Completed
Atrium Health Wake Forest Baptist Medical Center /ID# 264382	Winston-Salem	North Carolina	Recruiting
Ohio State Havener Eye Institute - Columbus /ID# 266253	Columbus	Ohio	Recruiting
Erlanger Health System /ID# 266608	Chattanooga	Tennessee	Recruiting
East Tennessee State University /ID# 264321	Johnson City	Tennessee	Recruiting
The University of Texas MD Anderson Cancer Center /ID# 264020	Houston	Texas	Recruiting
The Plastics Clinic and Spa /ID# 281483	Draper	Utah	Not Yet Recruiting
University of Virginia /ID# 265098	Charlottesville	Virginia	Completed
AG Aesthetic Center /ID# 264233	Vancouver	Washington	Completed

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06575192 on ClinicalTrials.gov ↗ ← All trials in the USA