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

Launched by ABBVIE · Aug 26, 2024

Keywords

ClinConnect Summary

This clinical trial, called the ADORA study, is looking at a new method for breast reconstruction after a mastectomy, which is the surgical removal of one or both breasts. Specifically, the trial is testing the ARTIA Reconstructive Tissue Matrix to see if it is safe and effective for women who are having immediate breast reconstruction after their surgery. The study is currently recruiting women aged 65 to 74 who are planning to undergo a unilateral (one breast) or bilateral (both breasts) mastectomy and are willing to have this type of reconstruction.

If you or someone you know is considering joining this trial, it’s important to note that participants must be healthy enough to undergo surgery and should not have any existing breast cancer that has not been treated or any serious health issues that could affect healing. Those who take part in the study will receive either the ARTIA treatment or a standard method for breast reconstruction. This trial aims to help improve options for breast reconstruction, making it a significant opportunity for eligible patients.

Gender

FEMALE

Eligibility criteria

• 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.