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Clinical Trials in the USA / NCT06575192
Recruiting Phase 3

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
No
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)

FacilityCityRegionStatus
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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Other trials for the same condition

A Study of the Safety and Effectiveness of the Mentor Larger Size MemoryGel Ultra High Profile Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction Active, not recruiting
Melodi Matrix™ in Breast Reconstruction Recruiting
Effectiveness and Safety of OviTex® PRS in Breast Reconstruction Recruiting
Acellular Dermal Matrix Investigation in Breast Reconstruction Recruiting
Sientra Post-Approval Study Active, not recruiting
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