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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAbbVie

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • ARTIA Reconstructive Tissue Matrix

Treatment groups

264 Participants
are divided into 1 treatment group

Sponsors and collaborators