RECRUITING

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

Description

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.

Conditions

Breast Reconstruction
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Related Conditions:

Breast Reconstruction

Study Overview

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Study Details

Study 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.

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

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

Condition
Breast Reconstruction
Intervention / Treatment

-

Contacts and Locations

Las Vegas

University of Nevada - Main Campus /ID# 264017, Las Vegas, Nevada, United States, 89154

Newark

Rutgers New Jersey Medical School - Newark /ID# 264187, Newark, New Jersey, United States, 07103

New York

NYU Langone Medical Center /ID# 265621, New York, New York, United States, 10016-6402

Chattanooga

Erlanger Health System /ID# 266608, Chattanooga, Tennessee, United States, 37403

Houston

The University of Texas MD Anderson Cancer Center /ID# 264020, Houston, Texas, United States, 77030

Vancouver

AG Aesthetic Center /ID# 264233, Vancouver, Washington, United States, 98660

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

AbbVie,

ABBVIE INC., STUDY_DIRECTOR, AbbVie

Study Record Dates

2029-12