Spots Global Cancer Trial Database for External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery Evaluation in Breast Reconstructive Surgery
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Trial Identification
Brief Title: External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery Evaluation in Breast Reconstructive Surgery
Official Title: External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery
Study ID: NCT05003635
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 23 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Maastricht University Medical Center+, Maastricht, Limburg, Netherlands
Amsterdam University Medical Center (VUMC), Amsterdam, , Netherlands
Ziekenhuis groep Twente (ZGT), Hengelo, , Netherlands
Contact Details
Name: Andrzej Piatkowski de Gryzmala, MD, MsC
Affiliation: Maastricht University Medical Center
Role: PRINCIPAL_INVESTIGATOR
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