New hybrid breast reconstruction combines fat grafting and implants for natural results
NCT ID NCT06146231
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 66 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2023
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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.
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The places running it
4 sites in 4 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Hospital UNIBE
NOT_YET_RECRUITINGSan José, Costa Rica
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Hospital Universitario San Ignacio
NOT_YET_RECRUITINGBogotá, Colombia
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Hospital de la Santa Creu i Sant Pau
RECRUITINGBarcelona, Spain
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Universitair Ziekenhuis Gent
RECRUITINGGhent, Belgium
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