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

Study Identifier
M24-708
CT.gov Identifier
NCT06575192
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Recruiting
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Study Details

Medical Condition
  • Breast Reconstruction
    • Study Drug
    N/A
    Phase
    Phase 3
    Sex
    Female
    Age
    18+ years
    Inclusion and Exclusion Criteria
    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.

    Protocol Summary

    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 Locations

    Location
    Status
    Location
    Cedars-Sinai Medical Center /ID# 268326
    Los Angeles, California, United States, 90048
    Status
    Recruiting
    Location
    University Of California Irvine Medical Center /ID# 267428
    Orange, California, United States, 92868
    Status
    Recruiting
    Location
    Stanford University Medical Center CTRU - 800 Welch Road /ID# 264196
    Palo Alto, California, United States, 94304
    Status
    Recruiting
    Location
    South Bay Plastic Surgeons /ID# 264192
    Torrance, California, United States, 90505
    Status
    Completed
    Location
    University Of Colorado - Anschutz Medical Campus /ID# 268627
    Aurora, Colorado, United States, 80045
    Status
    Recruiting
    Location
    Private Practice - Dr. Wayne Lee /ID# 281661
    Brandon, Florida, United States, 33511
    Status
    Not yet recruiting
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