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

AbbVie

Status and phase: Enrolling; Phase 3

Conditions: Breast Reconstruction

Treatments: Other: No Intervention; Device: ARTIA Reconstructive Tissue Matrix

Study type: Interventional

Funder types: Industry

Identifiers

NCT06575192

M24-708

Details and patient eligibility

About

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.

Enrollment: 783 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

783 participants in 2 patient groups

Acellular Dermal Matrix

Experimental group

Description:

Breast reconstruction with ARTIA Tissue Matrix.

Treatment:

Device: ARTIA Reconstructive Tissue Matrix

Non-Acellular Dermal Matrix (ADM) Control Group

Other group

Description:

Breast reconstruction without ADM.

Treatment:

Other: No Intervention