RecruitingNCT04261829

AFT: Introduction of a Full Breast Reconstructive Method

Autologous Fat Transfer: Introduction of a Full Breast Reconstructive Method


Sponsor

Maastricht University Medical Center

Enrollment

350 participants

Start Date

Dec 9, 2020

Study Type

OBSERVATIONAL

Conditions

Summary

A multicentre prospective cohort study will monitor the efficacy and safety of Autologous Fat Transfer (AFT) with pre-expansion. AFT will be evaluated in terms of quality of life, aesthetic result, complications, oncological safety and cost-effectiveness. It follows the BREAST trial, the randomised controlled trial comparing AFT with implant-based reconstruction. In this study, patients all receive AFT.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a breast reconstruction method called autologous fat transfer (AFT) — which uses the patient's own fat to rebuild the breast after a mastectomy — to assess how well it works and how satisfied patients are with the results. **You may be eligible if:** - You are a woman aged 18 or older - You have had or are planning to have a mastectomy (breast removal) for cancer or as a preventive measure - You want to have breast reconstruction - You are able to wear the external expansion device used before the procedure **You may NOT be eligible if:** - You are an active smoker or stopped smoking less than 4 weeks before surgery - You have had radiation therapy to the breast area in the past - You plan to have radiation after your mastectomy - You have uncontrolled diabetes, kidney disease, or a compromised immune system - You are currently on chemotherapy (must be at least 4 weeks after your last dose) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAutologous Fat Transfer

Female breast cancer patients who were surgically treated with mastectomy could opt for a full breast reconstruction with Autologous Fat Transfer in combination with external expansion.


Locations(8)

Maastricht University Medical Center+

Maastricht, Limburg, Netherlands

Viecuri Venlo

Venlo, Limburg, Netherlands

Amsterdam University Medical Center (VUMC)

Amsterdam, Netherlands

Rijnstate

Arnhem, Netherlands

Alexander Monro, Bilthoven

Bilthoven, Netherlands

Amphia

Breda, Netherlands

Ziekenhuis groep Twente (ZGT)

Hengelo, Netherlands

Medical Center Leeuwarden

Leeuwarden, Netherlands

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NCT04261829


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