Evaluation of the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix Breast Reconstruction (ADORA) in Adult Participants
NCT ID: NCT06575192
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
783 participants
INTERVENTIONAL
2024-11-05
2029-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Acellular Dermal Matrix
Breast reconstruction with ARTIA Tissue Matrix.
ARTIA Reconstructive Tissue Matrix
Surgical Implant
Non-Acellular Dermal Matrix (ADM) Control Group
Breast reconstruction without ADM.
No Intervention
No ADM
Interventions
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ARTIA Reconstructive Tissue Matrix
Surgical Implant
No Intervention
No ADM
Eligibility Criteria
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Inclusion Criteria
* Participants who are willing and able to undergo immediate pre-pectoral two-stage breast reconstruction with ARTIA or without ADM.
Exclusion Criteria
* Has any disease which is clinically known to impact wound healing ability, such as uncontrolled diabetes or history of compromised wound healing.
18 Years
FEMALE
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Cedars-Sinai Medical Center /ID# 268326
Los Angeles, California, United States
UC Irvine Medical Center /ID# 267428
Orange, California, United States
Stanford University Medical Center CTRU - 800 Welch Road /ID# 264196
Palo Alto, California, United States
South Bay Plastic Surgeons /ID# 264192
Torrance, California, United States
University of Florida College of Medicine /ID# 267485
Gainesville, Florida, United States
Endeavor Health /ID# 266302
Northbrook, Illinois, United States
Johns Hopkins Hospital /ID# 265917
Baltimore, Maryland, United States
Washington University School of Medicine - St. Louis /ID# 264029
St Louis, Missouri, United States
University of Nevada - Main Campus /ID# 264017
Las Vegas, Nevada, United States
Rutgers New Jersey Medical School - Newark /ID# 264187
Newark, New Jersey, United States
Northwell Health Clinical Trials Office /ID# 268076
Lake Success, New York, United States
NYU Langone Medical Center /ID# 265621
New York, New York, United States
Atrium Health Wake Forest Baptist Medical Center /ID# 264382
Winston-Salem, North Carolina, United States
Ohio State University Comprehensive Cancer Center /ID# 266253
Columbus, Ohio, United States
Erlanger Health System /ID# 266608
Chattanooga, Tennessee, United States
The University of Texas MD Anderson Cancer Center /ID# 264020
Houston, Texas, United States
University of Virginia /ID# 265098
Charlottesville, Virginia, United States
AG Aesthetic Center /ID# 264233
Vancouver, Washington, United States
Countries
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Central Contacts
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Related Links
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Other Identifiers
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M24-708
Identifier Type: -
Identifier Source: org_study_id