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AFT: Introduction of a Full Breast Reconstructive Method | Clinical Trials | Clareo Health

RECRUITING

AFT: Introduction of a Full Breast Reconstructive Method

Autologous Fat Transfer: Introduction of a Full Breast Reconstructive Method

NCT04261829•Maastricht University Medical Center

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

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Female gender
•Age of 18 years and older
•History or in candidate for a mastectomy procedure in the near future
•Patients undergoing preventive mastectomy
•Patients' choice to undergo a breast reconstruction
•Wanting to participate in this study
•Patient is able to wear the external expansion device

Exclusion Criteria

•Active smoker or a history of smoking 4 weeks prior to surgery
•Current substance abuse
•History of lidocaine allergy
•History of silicone allergy
•4 weeks or less after chemotherapy
•History of radiation therapy in the breast region
•Oncological treatment includes radiotherapy after mastectomy
•Kidney disease
•Steroid dependent asthma (daily or weekly) or other diseases
•Immune-suppressed or compromised disease
+5 more criteria

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

Key Dates

Start Date

December 9, 2020

Primary Completion Date

October 1, 2026

Completion Date

October 1, 2026

Last Updated

July 29, 2021

Enrollment

350

ESTIMATED participants

Conditions

Breast CancerReconstructive SurgeryBreast Reconstruction

Interventions

Autologous Fat Transfer

PROCEDURE

Contacts

Jamilla Wederfoort, MD, MSc

CONTACT

0031-(0)43 387 2308 sander.schop@mumc.nl

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 29, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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AFT: Introduction of a Full Breast Reconstructive Method

Inclusion Criteria

Exclusion Criteria

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