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RecruitingPhase 3

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

AbbVie · NCT06575192

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · Women only
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
264
US sites recruiting
15
Study start
November 5, 2024
Record last updated
August 6, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: ARTIA Reconstructive Tissue Matrix

Conditions: Breast Reconstruction

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • Cedars-Sinai Medical Center /ID# 268326

    Los Angeles, CA 90048

  • University Of California Irvine Medical Center /ID# 267428

    Orange, CA 92868

  • Stanford University Medical Center CTRU - 800 Welch Road /ID# 264196

    Palo Alto, CA 94304

  • University Of Colorado - Anschutz Medical Campus /ID# 268627

    Aurora, CO 80045

  • University of Florida College of Medicine /ID# 267485

    Gainesville, FL 32610

  • Rush University Medical Center /ID# 275935

    Chicago, IL 60612-3841

  • Endeavor Health - Health Center & Immediate Care - Northbrook /ID# 266302

    Northbrook, IL 60062

  • Johns Hopkins Hospital /ID# 265917

    Baltimore, MD 21287

  • Washington University /ID# 264029

    St Louis, MO 63110

  • Rutgers New Jersey Medical School - Newark /ID# 264187

    Newark, NJ 07103

  • Atrium Health Wake Forest Baptist Medical Center /ID# 264382

    Winston-Salem, NC 27157

  • Ohio State Havener Eye Institute - Columbus /ID# 266253

    Columbus, OH 43212

  • Erlanger Health System /ID# 266608

    Chattanooga, TN 37403

  • East Tennessee State University /ID# 264321

    Johnson City, TN 37614

  • The University of Texas MD Anderson Cancer Center /ID# 264020

    Houston, TX 77030

Study contacts (from the official record)

  • ABBVIE CALL CENTER · 844-663-3742 · abbvieclinicaltrials@abbvie.com
Evaluation of the Safety and Effectiveness of ARTIA Reconstructive… (NCT06575192) | Bored Studies