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

Phase 3RecruitingNCT06575192

AbbVie783 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

783

Conditions

Breast Reconstruction

Interventions

ARTIA Reconstructive Tissue MatrixDEVICE

Surgical Implant

No InterventionOTHER

No ADM

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (20)

Cedars-Sinai Medical Center /ID# 268326

Outcomes

Primary Outcomes

Occurrence of at Least One Major Complication related to Breast Reconstruction After Stage 1

Number of participants with at least one major complication related to breast reconstruction.

Time frame: Month 18

Change from Baseline in BREAST-Q Satisfaction with Breasts Score from Pre-Mastectomy After Stage 2

Participants evaluated satisfaction with their breasts using the BREAST-Q. Summary scores were computed by summing the score of each response and transferring them to a 0 (worst) to 100 (best) scale.

Time frame: Up to Month 18

Number of Participants with Adverse Events (AEs)

An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a medical device which does not necessarily have a causal relationship with this treatment.

Time frame: Up to Approximately 36 Months

Secondary Outcomes

Occurrence of Capsular Contracture per Breast

Number of participants with an occurrence of capsular contracture per breast.

Time frame: Month 36

Central Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742 abbvieclinicaltrials@abbvie.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.