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

a study on Breast Reconstruction

Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
completion around

Description

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.

Official Title

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

Keywords

Breast Reconstruction, ADORA, ARTIA, ARTIA Reconstructive Tissue Matrix, Acellular Dermal Matrix

Eligibility

You can join if…

Open to females ages 18 years and up

  • 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.

You CAN'T join if...

  • 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

  • UC Irvine Medical Center /ID# 267428 accepting new patients
    Orange California 92868-3201 United States
  • South Bay Plastic Surgeons /ID# 264192 accepting new patients
    Torrance California 90505-3927 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
Related Info
ID
NCT06575192
Phase
Phase 3 Breast Reconstruction Research Study
Study Type
Interventional
Participants
Expecting 783 study participants
Last Updated
Contact us about this trial