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

AbbVie

Summary

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.

Eligibility

Age range: 18+ years
Sex: Female
Healthy volunteers: No

Detailed criteria

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.

Locations (23)

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

Summary

Eligibility

Interventions

Locations (23)