Actively Recruiting
External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery Evaluation in Breast Reconstructive Surgery
Led by Maastricht University Medical Center · Updated on 2022-08-03
90
Participants Needed
3
Research Sites
272 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
This multicentre randomized controlled trial aims to evaluate a new breast reconstruction technique- autologous fat transfer (AFT). Female patients with breast cancer schedule to receive a mastectomy (or having undergone mastectomy in the past) will be randomized to undergo breast reconstruction with either AFT with the EVEBRA device(intervention group) or AFT without the EVEBRA device (control group). AFT will be evaluated in terms of volume, quality of life, aesthetic result, complications and oncological safety.
CONDITIONS
Official Title
External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery Evaluation in Breast Reconstructive Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female
- Age between 23 and 69 years
- Body mass index (BMI) between 18 and 35 with stable weight and no fluctuations
- Have undergone a total mastectomy at least 3 months before the study, with no removal of the pectoralis muscle
- Agrees to breast reconstruction involving only autologous fat grafting
- Assessed by surgeon to have enough donor fat for the procedure
- Passes a 20-minute tolerance test with the EVEBRA device, feeling comfortable and able to comply with its use
You will not qualify if you...
- Untreated breast cancer
- History of radiation therapy on the involved breast
- Completed chemotherapy less than 2 months before the study (aromatase inhibitors allowed)
- Had breast surgery before mastectomy except biopsy (e.g., multiple biopsies, implant augmentation, mastopexy, fat grafting)
- Experienced wound healing complications after mastectomy such as seroma, wound breakdown, or infection
- Mastectomy scar or defect with significant skin excess and deep folds stuck to the chest wall
- Has a pacemaker or aneurysm clips
- Pregnant or breastfeeding
- Had a cardiac stent placed within the last 2 months
- Claustrophobic
- Known current substance abuse
- History of allergy to silicone, Gadolinium, or lidocaine
- Has bleeding disorders
- Smokes cigarettes or uses smokeless tobacco
- Has medical conditions preventing breast reconstruction including uncontrolled hypertension or diabetes, kidney failure, steroid-dependent asthma, or is on immunosuppressant medications
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Trial Site Locations
Total: 3 locations
1
Maastricht University Medical Center+
Maastricht, Limburg, Netherlands, 6229 HX
Actively Recruiting
2
Amsterdam University Medical Center (VUMC)
Amsterdam, Netherlands
Actively Recruiting
3
Ziekenhuis groep Twente (ZGT)
Hengelo, Netherlands
Actively Recruiting
Research Team
M
Maud Rijkx, MD, MsC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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