Evaluating a new method for breast reconstruction after mastectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

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 it's running

• Cedars-Sinai Medical Center /ID# 268326
  Los Angeles, California, United States Recruiting
• University Of California 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
• 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

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.