RecruitingPhase 3NCT06575192

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

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

Sponsor

AbbVie

Enrollment

264 participants

Start Date

Nov 5, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Reconstruction

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: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called ARTIA Reconstructive Tissue Matrix for people with breast reconstruction. The study is currently recruiting participants at 22 locations. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEARTIA Reconstructive Tissue Matrix

Surgical Implant

Locations(22)

Cedars-Sinai Medical Center /ID# 268326

Los Angeles, California, United States

University Of California Irvine Medical Center /ID# 267428

Orange, California, United States

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

Palo Alto, California, United States

South Bay Plastic Surgeons /ID# 264192

Torrance, California, United States

University Of Colorado - Anschutz Medical Campus /ID# 268627

Aurora, Colorado, United States

Private Practice - Dr. Wayne Lee /ID# 281661

Brandon, Florida, United States

University of Florida College of Medicine /ID# 267485

Gainesville, Florida, United States

Rush University Medical Center /ID# 275935

Chicago, Illinois, United States

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

Northbrook, Illinois, United States

Johns Hopkins Hospital /ID# 265917

Baltimore, Maryland, United States

Washington University /ID# 264029

St Louis, Missouri, United States

University of Nevada - Main Campus /ID# 264017

Las Vegas, Nevada, United States

Rutgers New Jersey Medical School - Newark /ID# 264187

Newark, New Jersey, United States

Northwell Health Clinical Trials Office /ID# 268076

Lake Success, New York, United States

NYU Langone Medical Center /ID# 265621

New York, New York, United States

Atrium Health Wake Forest Baptist Medical Center /ID# 264382

Winston-Salem, North Carolina, United States

Ohio State Havener Eye Institute - Columbus /ID# 266253

Columbus, Ohio, United States

Erlanger Health System /ID# 266608

Chattanooga, Tennessee, United States

East Tennessee State University /ID# 264321

Johnson City, Tennessee, United States

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

Houston, Texas, United States

University of Virginia /ID# 265098

Charlottesville, Virginia, United States

AG Aesthetic Center /ID# 264233

Vancouver, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06575192

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