This study will monitor the safety of FS VH S/D and will evaluate whether FS VH S/D is superior to conventional surgical procedures in the reduction of lymphatic leakage by sealing the axillary lymphatics in subjects undergoing lumpectomy and level I and II axillary lymph node dissection with two separate incisions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Landeskrankenhaus St. Pölten
Sankt Pölten, Lower Austria, Austria
Allgemeines Krankenhaus der Stadt Wien, University Clinic for Gynecology
Vienna, Austria
Centre Régional de Lutte Contre le Cancer, Centre Eugène Marquis
Rennes, France
Ludwig-Maximilians-Universität
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Munich, Germany
Universitätsklinikum Tübingen, Frauenklinik
Tübingen, Germany
Universitätsklinikum - Frauenklinik
Würzburg, Germany
S. Luigi - S. Curro, Presidi Ospedalieri Unificati
Catania, Italy
Istituto Nationale per la Ricerca sul Cancro
Genova, Italy