Clinical Trial

AFT: Introduction of a Full Breast Reconstructive Method

Study acronym: BREAST-II
Recruiting
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2020-02-06.
Status change: Not Yet Recruiting → Recruiting 2021-07-22
Trial Details
NCT Number NCT04261829
Lead Sponsor Maastricht University Medical Center
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
Conditions Breast Cancer, Reconstructive Surgery, Breast Reconstruction
Enrollment 350 participants
Start Date 2020-12-09
Primary Completion 2026-10 (estimated)
Study Completion 2026-10 (estimated)
Updated on ClinicalTrials.gov 2021-07-29