Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New material could make breast reconstruction safer and better

NCT ID NCT06456554

Disease control Sponsor: RTI Surgical 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a special material (acellular dermal matrix) used in a two-stage breast reconstruction procedure for women who have had a mastectomy. The goal is to see if it reduces complications like infections or the need for extra surgeries, and improves quality of life. About 467 women will take part across multiple centers.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 467 people

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

Started

Nov 2024

Expected to finish

Dec 2027

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

22 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Genetic female * Age 22 or older at time of consent * Undergoing immediate breast reconstruction * 2 stage breast reconstruction using pre pectoral technique * Nipple or skin sparing mastectomy * Willing and capable of providing informed consent * Able to comply with study requirements Exclusion Criteria: * Planned concurrent reconstruction with pedicled flaps or free tissue * Pregnant or breast feeding * Investigator has determined tissue is unsuitable for two-stage breast reconstruction * History of psychological characteristics that may be incompatible with the surgical procedure and the prosthesis * Any serious and/or unstable pre-existing medical disorder or other conditions that could interfere with the subject's safety, the informed consent process, or compliance with the study protocol, in the opinion of the investigator * Vulnerable subject populations * Currently participating in another clinical trial that would have the potential to interfere or conflict with the treatment, follow-up, or objectives of this study * Prior history of neoadjuvant radiotherapy to the reconstruction site or chest wall * Active abscess or infection in the intended reconstruction site * Residual gross tumor at the intended reconstruction site * Active use of any tobacco/nicotine products * Has body mass index (BMI) \>35 * Uncontrolled diabetes defined as HbA1c ≥7 within 3 months prior to stage 1 procedure * Is currently taking medications including systemic steroids

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Breast reconstruction are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

    13 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

  • City of Hope National Medical Center

    RECRUITING

    Duarte, California, 91010, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • MD Anderson

    RECRUITING

    Houston, Texas, 77030, United States

  • Mercy

    RECRUITING

    Oklahoma City, Oklahoma, 73120, United States

  • Mercy Hospital

    RECRUITING

    St Louis, Missouri, 63141, United States

  • Mercy Hospital

    NOT_YET_RECRUITING

    Oklahoma City, Oklahoma, 73120, United States

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • New York Presbyterian Hospital/Columbia University Irving Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • University of Arkansas

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • University of Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Kansas

    RECRUITING

    Lawrence, Kansas, 66045, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Washington University

    RECRUITING

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.