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Breast reconstruction technique under the microscope: global registry tracks implant placement in front of the muscle

NCT ID NCT05817175

Knowledge-focused Sponsor: European Breast Cancer Research Association of Surgical Trialists 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Last updated Sep 11, 2026

Summary

This international registry collects data on women who have breast reconstruction with implants placed in front of the chest muscle (pre-pectoral) after mastectomy for breast cancer. Researchers follow participants for surgical complications, aesthetic results, cancer outcomes, and quality of life. The goal is to understand how this approach performs in real-world practice and how it compares with other techniques.

What this could mean

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

Active substance
pre-pectoral breast reconstruction, a surgical technique that places implants in front of the chest muscle after mastectomy
What this could lead to
If the registry shows good outcomes, it could help standardize pre-pectoral reconstruction and give women clearer expectations about recovery and appearance.
What could go wrong
This is an observational registry, not a controlled experiment, so it cannot prove one technique is better than another. Results may be biased by which surgeons and patients choose each approach.

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.

Participants

About 1,236 people

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

Started

Sep 2023

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

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

Who is studied

All patients who are candidates for implant-based reconstruction should be informed about the possible participation to this clinical study. The inclusion and exclusion criteria are verified by the investigator and an informed consent is obtained from the patient. The therapeutic pattern should be followed according to institutional and national standards. Since this is a non-interventional trial, the study sites do not deviate from their own study protocol at any timepoint.

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: * Female patients older than 18 years old * Signed informed consent form * Patients undergoing mono or bilateral therapeutic mastectomy * Patients undergoing pre-pectoral implant-based breast reconstruction with implant or expander with or without mesh Exclusion Criteria: * Male patients * Patients not suitable for surgical treatment * Patients undergoing subpectoral reconstruction * Patients undergoing breast reconstruction with autologous tissue.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

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

Breast cancer

How to take part

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

  1. The places running it

    11 sites in 9 countries. 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

  • Fondazione Policlinico Universitario Agostino Gemelli

    RECRUITING

    Roma, RM, 00136, Italy

  • Hospital del Mar

    RECRUITING

    Barcelona, Spain

  • Mansoura Insurance

    RECRUITING

    Al Mansurah, Egypt

  • Mansoura Oncology

    RECRUITING

    Al Mansurah, Egypt

  • Marmara University School of medicine

    RECRUITING

    Istanbul, Turkey (Türkiye)

  • National ans Kapodistrian University of Athens

    RECRUITING

    Athens, Greece

  • Ospedale San Raffaele

    RECRUITING

    Milan, MI, 20132, Italy

  • Prof. Dr. Ion Chiricuta Institute of Oncology

    RECRUITING

    Cluj-Napoca, Romania

  • University Hospital of Karol Marcinkowski

    RECRUITING

    Zielona Góra, Poland

  • University Hospitals of Leicester

    RECRUITING

    Leicester, United Kingdom

  • Univesidad de Buenos Aires

    RECRUITING

    Buenos Aires, Argentina

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