External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery Evaluation in Breast Reconstructive Surgery
Recruiting
N/A
Interventional Study
Breast Cancer Female
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 23 – 69
- Sex
- Female
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 90 (estimated)
- Sponsor
- Maastricht University Medical Center · Other
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About This Trial
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 gr…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Female
* Age 23-69
* BMI 18-35 - stable weight, no fluctuations
* Have undergone a total mastectomy at least 3 months prior the study, whether therapeutic or prophylactic, whether unilateral or bilateral, with no resection of the pectoralis muscle
* Agrees to have reconstructi…
Contacts