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New hybrid breast reconstruction combines fat grafting and implants for natural results

NCT ID NCT06146231

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 new breast reconstruction method for women who have had breast cancer or have Poland syndrome. The approach uses a special tissue expander to stretch the skin, followed by fat grafting from the patient's own body, and finally a permanent breast implant. The goal is to improve the look and feel of the reconstructed breast. The study will enroll 66 participants and track safety and satisfaction over about 2 years.

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 66 people

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

Started

Aug 2023

Expected to finish

Apr 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

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: 1. Genetically female, aged 18 years or older. 2. Subjects who had provided written informed consent form. 3. The participant needs tissue expansion as part of breast reconstruction treatment, which may include immediate reconstruction. 4. Clinical condition to allow reverse expansion breast reconstruction, at the investigator's discretion. 5. Sufficient fat in donor sites (abdomen, gluteus, hips, and thighs) per plastic surgeon criteria. 6. Complete radiotherapy and chemotherapy at least one year before surgery. 7. BMI between 18.5 and 30.0 (average classified weight). 8. Physical and cognitive capacity to understand and follow the surgeon's recommendations. 9. To be able and willing to comply with all study requirements, including attending follow-up appointments. Only Sub study participants 10. Provide additional consent to undergo an MRI with contrast. Exclusion Criteria: 1. Current pregnancy or lactation, or full-term pregnancy or lactation at any point during the clinical investigation. 2. Abnormal hematological and biochemical values after chemotherapy. 3. High surgical risk according to the investigator. 4. Breast width larger than 18 cm 5. Tumor residues in or near the area where tissue expansion is performed. 6. Subjects with metastatic breast cancer 7. Significant Breast ptosis or poor skin quality 8. Participants who do not have adequate tissue at the intended site for expansion, at the surgeon's discretion, due to previous radiotherapy, ulceration, vascular involvement, history of impaired wound healing, or mastectomy scar deformity. 9. Inadequate chest wall tissue due to damage caused by radiotherapy, tight skin grafts, or radical resection of the pectoralis major muscle. 10. Current or previous infection in the area where the expansion occurs. 11. Any condition that impedes magnetic resonance imaging (MRI), including implanted metal device, claustrophobia, or other ailments that would prohibit MRI scan. 12. Presence of autoimmune diseases such as lupus or scleroderma, or immunocompromised participants due to immunosuppressive or steroid therapy. 13. History of silicone sensitivity. 14. Active smokers 15. Previous attempts of breast reconstruction 16. Subjects who, in the opinion of the investigator, are considered part of any vulnerable population 17. Subjects with affiliation to the Sponsor, sites or investigators, including relatives. 18. Participants who do not live in the procedure's country make it impossible to assist in follow-up visits. 19. Subjects who are participating in other investigation(s) which may affect the outcomes or ability to comply follow-up requirements of this study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    4 sites in 4 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

  • Hospital UNIBE

    NOT_YET_RECRUITING

    San José, Costa Rica

  • Hospital Universitario San Ignacio

    NOT_YET_RECRUITING

    Bogotá, Colombia

  • Hospital de la Santa Creu i Sant Pau

    RECRUITING

    Barcelona, Spain

  • Universitair Ziekenhuis Gent

    RECRUITING

    Ghent, Belgium

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