Actively Recruiting
AFT: Introduction of a Full Breast Reconstructive Method
Led by Maastricht University Medical Center · Updated on 2021-07-29
350
Participants Needed
8
Research Sites
303 weeks
Total Duration
On this page
Sponsors
M
Maastricht University Medical Center
Lead Sponsor
Z
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
AFT: Introduction of a Full Breast Reconstructive Method
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female gender
- Age of 18 years and older
- History or 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
You will not qualify if you...
- Active smoker or history of smoking within 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
- Uncontrolled diabetes
- BMI greater than 30
- Large breast size (larger than cup C) unless patient prefers contralateral reduction
- Extra-capsular silicone leakage from encapsulated implant from previous breast reconstruction
- Treating plastic surgeon has strong doubts about patient's treatment compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Maastricht University Medical Center+
Maastricht, Limburg, Netherlands, 6229 HX
Enrolling by Invitation
2
Viecuri Venlo
Venlo, Limburg, Netherlands
Actively Recruiting
3
Amsterdam University Medical Center (VUMC)
Amsterdam, Netherlands
Enrolling by Invitation
4
Rijnstate
Arnhem, Netherlands
Enrolling by Invitation
5
Alexander Monro, Bilthoven
Bilthoven, Netherlands
Enrolling by Invitation
6
Amphia
Breda, Netherlands
Enrolling by Invitation
7
Ziekenhuis groep Twente (ZGT)
Hengelo, Netherlands
Actively Recruiting
8
Medical Center Leeuwarden
Leeuwarden, Netherlands
Actively Recruiting
Research Team
J
Jamilla Wederfoort, MD, MSc
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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