Evaluating a new method for breast reconstruction after mastectomy
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
This study is testing a new method for breast reconstruction using the ARTIA Reconstructive Tissue Matrix to see if it works better than the standard care for women who have had a mastectomy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 783 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 21 sites (Los Angeles, California and 20 other locations) |
| Trial ID | NCT06575192 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of the ARTIA Reconstructive Tissue Matrix in adult participants who are undergoing immediate, two-stage, implant-based breast reconstruction following mastectomy. Participants will be enrolled to receive either the ARTIA matrix or standard care without an acellular dermal matrix (ADM). The study aims to determine how well this new approach works in improving outcomes for breast reconstruction. It is a Phase 3 interventional trial, indicating a focus on confirming effectiveness and monitoring side effects.
Who should consider this trial
Good fit: Ideal candidates are adults who are scheduled for unilateral or bilateral mastectomy and are willing to undergo immediate breast reconstruction.
Not a fit: Patients with existing breast carcinoma not undergoing mastectomy or those with conditions affecting wound healing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective option for breast reconstruction after mastectomy.
How similar studies have performed: Other studies have shown promise with similar reconstructive techniques, but the ARTIA matrix approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants who will undergo unilateral or bilateral mastectomy upon enrollment. * Participants who are willing and able to undergo immediate pre-pectoral two-stage breast reconstruction with ARTIA or without ADM. 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.
Where this trial is running
Los Angeles, California and 20 other locations
- Cedars-Sinai Medical Center /ID# 268326 — Los Angeles, California, United States (Recruiting)
- UC Irvine Medical Center /ID# 267428 — Orange, California, United States (Recruiting)
- Stanford University Medical Center CTRU - 800 Welch Road /ID# 264196 — Palo Alto, California, United States (Recruiting)
- South Bay Plastic Surgeons /ID# 264192 — Torrance, California, United States (Completed)
- University Of Colorado - Anschutz Medical Campus /ID# 268627 — Aurora, Colorado, United States (Recruiting)
- University of Florida College of Medicine /ID# 267485 — Gainesville, Florida, United States (Recruiting)
- Rush University Medical Center /ID# 275935 — Chicago, Illinois, United States (Recruiting)
- Endeavor Health /ID# 266302 — Northbrook, Illinois, United States (Recruiting)
- Johns Hopkins Hospital /ID# 265917 — Baltimore, Maryland, United States (Recruiting)
- Washington University School of Medicine - St. Louis /ID# 264029 — St Louis, Missouri, United States (Recruiting)
- University of Nevada - Main Campus /ID# 264017 — Las Vegas, Nevada, United States (Recruiting)
- Rutgers New Jersey Medical School - Newark /ID# 264187 — Newark, New Jersey, United States (Recruiting)
- Northwell Health Clinical Trials Office /ID# 268076 — Lake Success, New York, United States (Recruiting)
- NYU Langone Medical Center /ID# 265621 — New York, New York, United States (Completed)
- Atrium Health Wake Forest Baptist Medical Center /ID# 264382 — Winston-Salem, North Carolina, United States (Recruiting)
- Ohio State University Comprehensive Cancer Center /ID# 266253 — Columbus, Ohio, United States (Recruiting)
- Erlanger Health System /ID# 266608 — Chattanooga, Tennessee, United States (Recruiting)
- East Tennessee State University /ID# 264321 — Johnson City, Tennessee, United States (Recruiting)
- The University of Texas MD Anderson Cancer Center /ID# 264020 — Houston, Texas, United States (Recruiting)
- University of Virginia /ID# 265098 — Charlottesville, Virginia, United States (Recruiting)
- AG Aesthetic Center /ID# 264233 — Vancouver, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.