RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-11-05
Study Completion:2029-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06575192

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants who will undergo unilateral or bilateral mastectomy upon enrollment.
  2. * Participants who are willing and able to undergo immediate pre-pectoral two-stage breast reconstruction with ARTIA or without ADM.
  1. * Has an existing carcinoma of the breast without planned mastectomy or residual gross local tumor of the breast after mastectomy.
  2. * Has any disease which is clinically known to impact wound healing ability, such as uncontrolled diabetes or history of compromised wound healing.

Contacts and Locations

Study Contact

ABBVIE CALL CENTER
CONTACT
844-663-3742
abbvieclinicaltrials@abbvie.com

Principal Investigator

ABBVIE INC.
STUDY_DIRECTOR
AbbVie

Study Locations (Sites)

University of Nevada - Main Campus /ID# 264017
Las Vegas, Nevada, 89154
United States
Rutgers New Jersey Medical School - Newark /ID# 264187
Newark, New Jersey, 07103
United States
NYU Langone Medical Center /ID# 265621
New York, New York, 10016-6402
United States
Erlanger Health System /ID# 266608
Chattanooga, Tennessee, 37403
United States
The University of Texas MD Anderson Cancer Center /ID# 264020
Houston, Texas, 77030
United States
AG Aesthetic Center /ID# 264233
Vancouver, Washington, 98660
United States

Collaborators and Investigators

Sponsor: AbbVie

  • ABBVIE INC., STUDY_DIRECTOR, AbbVie

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-05
Study Completion Date2029-12

Study Record Updates

Study Start Date2024-11-05
Study Completion Date2029-12

Terms related to this study

Keywords Provided by Researchers

  • Breast Reconstruction
  • ADORA
  • ARTIA

Additional Relevant MeSH Terms

  • Breast Reconstruction