๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-04

Evaluation of the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix Breast Reconstruction (ADORA) in Adult Participants (NCT06575192)

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

๐ŸŸข Recruiting Phase3 โš™๏ธ Medical Device Protocol Sponsor: AbbVie

๐Ÿฉบ 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: Review the eligibility criteria below.

Location: Cedars-Sinai Medical Center /ID# 268326 โ€” Los Angeles, California

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (23 Sites)

  • Cedars-Sinai Medical Center /ID# 268326 โ€” Los Angeles, California
  • University Of California Irvine Medical Center /ID# 267428 โ€” Orange, California
  • Stanford University Medical Center CTRU - 800 Welch Road /ID# 264196 โ€” Palo Alto, California
  • South Bay Plastic Surgeons /ID# 264192 โ€” Torrance, California
  • University Of Colorado - Anschutz Medical Campus /ID# 268627 โ€” Aurora, Colorado
  • Private Practice - Dr. Wayne Lee /ID# 281661 โ€” Brandon, Florida
  • University of Florida College of Medicine /ID# 267485 โ€” Gainesville, Florida
  • Rush University Medical Center /ID# 275935 โ€” Chicago, Illinois
  • Endeavor Health - Health Center & Immediate Care - Northbrook /ID# 266302 โ€” Northbrook, Illinois
  • Johns Hopkins Hospital /ID# 265917 โ€” Baltimore, Maryland
  • Washington University /ID# 264029 โ€” St Louis, Missouri
  • University of Nevada - Main Campus /ID# 264017 โ€” Las Vegas, Nevada
  • Rutgers New Jersey Medical School - Newark /ID# 264187 โ€” Newark, New Jersey
  • Northwell Health Clinical Trials Office /ID# 268076 โ€” Lake Success, New York
  • NYU Langone Medical Center /ID# 265621 โ€” New York, New York
  • Atrium Health Wake Forest Baptist Medical Center /ID# 264382 โ€” Winston-Salem, North Carolina
  • Ohio State Havener Eye Institute - Columbus /ID# 266253 โ€” Columbus, Ohio
  • Erlanger Health System /ID# 266608 โ€” Chattanooga, Tennessee
  • East Tennessee State University /ID# 264321 โ€” Johnson City, Tennessee
  • The University of Texas MD Anderson Cancer Center /ID# 264020 โ€” Houston, Texas
  • The Plastics Clinic and Spa /ID# 281483 โ€” Draper, Utah
  • University of Virginia /ID# 265098 โ€” Charlottesville, Virginia
  • AG Aesthetic Center /ID# 264233 โ€” Vancouver, Washington

๐Ÿ“ž Contact the Study Coordinator

Phone: (844) 663-3742

Email: abbvieclinicaltrials@abbvie.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ 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 ยง 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.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—