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Evaluation of the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
    Female
  • Healthy Volunteers
    No
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Objective

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.

Details

Full study 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
Protocol number OCR45830
ClinicalTrials.gov ID NCT06575192
Phase Phase 3

Eligibility

Inclusion 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.

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.

Lead researcher

  • Kalyan C Dadireddy, MD, MS, McH
    Plastic, Reconstructive and Cosmetic Surgeon
    Languages: Hindi, Tamil, Telugu

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  1. Step
    1

    Contact the research team

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    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

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  3. Step
    3

    Provide your consent to participate

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  4. Step
    4

    Participate

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