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New surgical mesh aims to improve breast reconstruction outcomes

NCT ID NCT06575192

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 07, 2026 · Updated 7 times

Summary

This study tests a device called ARTIA, a special tissue matrix used during implant-based breast reconstruction after mastectomy. About 264 adults who need immediate reconstruction will receive ARTIA to see if it reduces major complications like infection or implant failure. The goal is to offer a safer and more effective option for women rebuilding their breasts after cancer surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ARTIA Reconstructive Tissue Matrix (a surgical mesh device)
What this could lead to
If successful, ARTIA could provide a safer, more effective option for women undergoing implant-based breast reconstruction after mastectomy, potentially reducing complications.
What could go wrong
This is a pivotal study, but results may not apply to all patients. Risks include surgical complications like infection or implant failure, and the device may not outperform existing options.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 264 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Feb 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast reconstruction

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    17 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AG Aesthetic Center /ID# 264233

    COMPLETED

    Vancouver, Washington, 98660, United States

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

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Cedars-Sinai Medical Center /ID# 268326

    RECRUITING

    Los Angeles, California, 90048, United States

  • East Tennessee State University /ID# 264321

    RECRUITING

    Johnson City, Tennessee, 37614, United States

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

    RECRUITING

    Northbrook, Illinois, 60062, United States

  • Erlanger Health System /ID# 266608

    RECRUITING

    Chattanooga, Tennessee, 37403, United States

  • Johns Hopkins Hospital /ID# 265917

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • NYU Langone Medical Center /ID# 265621

    COMPLETED

    New York, New York, 10016-6402, United States

  • Northwell Health Clinical Trials Office /ID# 268076

    COMPLETED

    Lake Success, New York, 11042, United States

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

    RECRUITING

    Columbus, Ohio, 43212, United States

  • Private Practice - Dr. Wayne Lee /ID# 281661

    NOT_YET_RECRUITING

    Brandon, Florida, 33511, United States

  • Rush University Medical Center /ID# 275935

    RECRUITING

    Chicago, Illinois, 60612-3841, United States

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

    RECRUITING

    Newark, New Jersey, 07103, United States

  • South Bay Plastic Surgeons /ID# 264192

    COMPLETED

    Torrance, California, 90505, United States

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

    RECRUITING

    Palo Alto, California, 94304, United States

  • The Plastics Clinic and Spa /ID# 281483

    NOT_YET_RECRUITING

    Draper, Utah, 84020, United States

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

    RECRUITING

    Houston, Texas, 77030, United States

  • University Of California Irvine Medical Center /ID# 267428

    RECRUITING

    Orange, California, 92868, United States

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

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Florida College of Medicine /ID# 267485

    RECRUITING

    Gainesville, Florida, 32610, United States

  • University of Nevada - Main Campus /ID# 264017

    COMPLETED

    Las Vegas, Nevada, 89154, United States

  • University of Virginia /ID# 265098

    COMPLETED

    Charlottesville, Virginia, 22903, United States

  • Washington University /ID# 264029

    RECRUITING

    St Louis, Missouri, 63110, United States

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