The REMOVE study was an open-label, multicenter validation study on the removal of EpCAM-positive tumor cells from blood collected during tumor surgery using the CATUVAB Kit. The aim of the REMOVE clinical study was to demonstrate the safety and efficacy of the application of the new medical device CATUVAB to allow retransfusion of autologous erythrocyte product produced by an intraoperative blood salvage (IBS) device during oncological high blood loss surgery. The primary objective of the study was to demonstrate that CATUVAB device utilized during autologous blood salvage procedures (including LDFs) depletes intraoperative blood of EpCAM-positive tumor cells.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
136
inducing of aggreation of tumor cells and immune cells via trifunctional antibody and removal of aggregates
Kliniken der Stadt Köln gGmbH
Cologne, North Rhine-Westphalia, Germany
Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie Universitätsklinikum Frankfurt
Frankfurt, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz Klinik für Anästhesiologie
Mainz, Germany
Universitätsmedizin Mannheim, Klinik für Urologie und Urochirurgie
Mannheim, Germany
Klinikum Traunstein
Traunstein, Germany
Klinik und Poliklinik für Anästhesiologie, Intensivmedizin, Notfallmedizin und Schmerztherapie Universitätsklinikum Würzburg
Würzburg, Germany
depletion of EpCAM-positive tumor cells
Tumor cell count (Depletion) measured with Immun-histo chemistry staining and tumor cell counting in a Neubauer Chamber * a depletion to ≤10 cells per 100 mL EC, OR * if \<100.000 tumor cells have been detected before in IBS: a depletion by at least a factor of 103 in the EC (total) as compared to collected intraoperative blood (total), OR * if ≥100.000 tumor cells have been detected before in IBS: a depletion by at least a factor of 5x103 in the EC (total) as compared to collected intraoperative blood (total), in at least 95% of subjects after one IBS/LDF cycle using the Catuvab device. The primary endpoint will only be determined in subjects with EpCAM-positive tumor cells in salvaged blood and who receive retransfusion of the EC
Time frame: during surgery only
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