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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participants who will undergo unilateral or bilateral mastectomy upon enrollment. - Participants who are willing and able to undergo immediate prepectoral, implant based, two-stage breast reconstruction with ARTIA.

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Acellular Dermal Matrix 		Breast reconstruction with ARTIA Tissue Matrix.
  • Device: ARTIA Reconstructive Tissue Matrix
    Surgical Implant

Recruiting Locations

Cedars-Sinai Medical Center /ID# 268326
Los Angeles, California 90048

University Of California Irvine Medical Center /ID# 267428
Orange, California 92868

Stanford University Medical Center CTRU - 800 Welch Road /ID# 264196
Palo Alto, California 94304

University Of Colorado - Anschutz Medical Campus /ID# 268627
Aurora, Colorado 80045

University of Florida College of Medicine /ID# 267485
Gainesville, Florida 32610

Rush University Medical Center /ID# 275935
Chicago, Illinois 60612-3841

Endeavor Health - Health Center & Immediate Care - Northbrook /ID# 266302
Northbrook, Illinois 60062

Johns Hopkins Hospital /ID# 265917
Baltimore, Maryland 21287

Washington University /ID# 264029
St Louis, Missouri 63110

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

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

Atrium Health Wake Forest Baptist Medical Center /ID# 264382
Winston-Salem, North Carolina 27157

Ohio State Havener Eye Institute - Columbus /ID# 266253
Columbus, Ohio 43212

Erlanger Health System /ID# 266608
Chattanooga, Tennessee 37403

East Tennessee State University /ID# 264321
Johnson City, Tennessee 37614

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

AG Aesthetic Center /ID# 264233
Vancouver, Washington 98660

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.