Autologous Fat Transfer: Introduction of a Full Breast Reconstructive Method
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Netherlands
Amsterdam University Medical Center (VUMC)
ENROLLING_BY_INVITATION
Amsterdam
Rijnstate
ENROLLING_BY_INVITATION
Arnhem
Alexander Monro, Bilthoven
ENROLLING_BY_INVITATION
Bilthoven
Amphia
ENROLLING_BY_INVITATION
Breda
Ziekenhuis groep Twente (ZGT)
RECRUITING
Hengelo
Medical Center Leeuwarden
RECRUITING
Leeuwarden
Maastricht University Medical Center+
ENROLLING_BY_INVITATION
Maastricht
Viecuri Venlo
RECRUITING
Venlo
Contact Information
Primary
Jamilla Wederfoort, MD, MSc
sander.schop@mumc.nl
0031-(0)43 387 2308
Time Frame
Start Date: 2020-12-09
Estimated Completion Date: 2026-10
Participants
Target number of participants: 350
Treatments
Autologous Fat Transfer
Related Therapeutic Areas
Sponsors
Leads: Maastricht University Medical Center
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development