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

Recruiting now · Phase 3

Conditions studied: Breast Reconstruction

In brief

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.

Key facts

Study ID

NCT06575192

Run by

AbbVie

People needed

264

Starts

2024-11-05

Expected to finish

2031-02-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

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.

Where it is running

• Atrium Health Wake Forest Baptist Medical Center /ID# 264382 — Winston-Salem, North Carolina, United States (enrolling)
• Ohio State Havener Eye Institute - Columbus /ID# 266253 — Columbus, Ohio, United States (enrolling)
• Erlanger Health System /ID# 266608 — Chattanooga, Tennessee, United States (enrolling)
• East Tennessee State University /ID# 264321 — Johnson City, Tennessee, United States (enrolling)
• The University of Texas MD Anderson Cancer Center /ID# 264020 — Houston, Texas, United States (enrolling)
• University of Florida College of Medicine /ID# 267485 — Gainesville, Florida, United States (enrolling)
• Rush University Medical Center /ID# 275935 — Chicago, Illinois, United States (enrolling)
• Cedars-Sinai Medical Center /ID# 268326 — Los Angeles, California, United States (enrolling)
• Endeavor Health - Health Center & Immediate Care - Northbrook /ID# 266302 — Northbrook, Illinois, United States (enrolling)
• Johns Hopkins Hospital /ID# 265917 — Baltimore, Maryland, United States (enrolling)
• Washington University /ID# 264029 — St Louis, Missouri, United States (enrolling)
• University Of California Irvine Medical Center /ID# 267428 — Orange, California, United States (enrolling)
• Rutgers New Jersey Medical School - Newark /ID# 264187 — Newark, New Jersey, United States (enrolling)
• University Of Colorado - Anschutz Medical Campus /ID# 268627 — Aurora, Colorado, United States (enrolling)
• Stanford University Medical Center CTRU - 800 Welch Road /ID# 264196 — Palo Alto, California, United States (enrolling)
• AG Aesthetic Center /ID# 264233 — Vancouver, Washington, United States
• South Bay Plastic Surgeons /ID# 264192 — Torrance, California, United States
• Private Practice - Dr. Wayne Lee /ID# 281661 — Brandon, Florida, United States
• University of Nevada - Main Campus /ID# 264017 — Las Vegas, Nevada, 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
• The Plastics Clinic and Spa /ID# 281483 — Draper, Utah, United States
• University of Virginia /ID# 265098 — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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