🏛️ Verified NIH Record • Updated 2026-08-04
Evaluation of the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix Breast Reconstruction (ADORA) in Adult Participants (NCT06575192)
🟢 Recruiting Phase3 ⚙️ Medical Device Protocol Sponsor: AbbVie
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (2 items) and avoid the listed exclusions (3 items).
Location: Cedars-Sinai Medical Center /ID# 268326 — Los Angeles, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (23 Sites)
- Cedars-Sinai Medical Center /ID# 268326 — Los Angeles, California
- University Of California Irvine Medical Center /ID# 267428 — Orange, California
- Stanford University Medical Center CTRU - 800 Welch Road /ID# 264196 — Palo Alto, California
- South Bay Plastic Surgeons /ID# 264192 — Torrance, California
- University Of Colorado - Anschutz Medical Campus /ID# 268627 — Aurora, Colorado
- Private Practice - Dr. Wayne Lee /ID# 281661 — Brandon, Florida
- University of Florida College of Medicine /ID# 267485 — Gainesville, Florida
- Rush University Medical Center /ID# 275935 — Chicago, Illinois
- Endeavor Health - Health Center & Immediate Care - Northbrook /ID# 266302 — Northbrook, Illinois
- Johns Hopkins Hospital /ID# 265917 — Baltimore, Maryland
- Washington University /ID# 264029 — St Louis, Missouri
- University of Nevada - Main Campus /ID# 264017 — Las Vegas, Nevada
- Rutgers New Jersey Medical School - Newark /ID# 264187 — Newark, New Jersey
- Northwell Health Clinical Trials Office /ID# 268076 — Lake Success, New York
- NYU Langone Medical Center /ID# 265621 — New York, New York
- Atrium Health Wake Forest Baptist Medical Center /ID# 264382 — Winston-Salem, North Carolina
- Ohio State Havener Eye Institute - Columbus /ID# 266253 — Columbus, Ohio
- Erlanger Health System /ID# 266608 — Chattanooga, Tennessee
- East Tennessee State University /ID# 264321 — Johnson City, Tennessee
- The University of Texas MD Anderson Cancer Center /ID# 264020 — Houston, Texas
- The Plastics Clinic and Spa /ID# 281483 — Draper, Utah
- University of Virginia /ID# 265098 — Charlottesville, Virginia
- AG Aesthetic Center /ID# 264233 — Vancouver, Washington
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.