23
Participants
Start Date
September 30, 2013
Primary Completion Date
October 31, 2018
Study Completion Date
October 31, 2018
Electrochemotherapy
Treatment procedure: anesthesia, positioning of electrodes, intravenous in bolus administration of bleomycin, within 8-30 min after administration of bleomycin application of electric pulses, removal of electrodes.
Cliniporator Vitae®
Positioning of electrodes, within 8-30 min after administration of bleomycin application of electric pulses (8 pulses, duration 100 microseconds, frequency 4 Hz with amplitude adequate to cover the whole treated lesion with electric field necessary for reversible plasma membrane permeabilization), removal of electrodes.
Bleomycin PHC 15 e. (United States Pharmacopeia - USP)
Intravenous in bolus administration of bleomycin (15 mg/m2), 8 minutes before application of electric pulses
Faculty of Electrical Engineering, University of Ljubljana, Slovenia, Ljubljana
Institute of Oncology Ljubljana, Ljubljana
University Medical Centre Ljubljana, Ljubljana, Slovenia, Ljubljana
University Medical Centre Maribor, Maribor, Slovenia, Maribor
University Medical Centre Ljubljana
OTHER
University Medical Centre Maribor
OTHER
University of Ljubljana
OTHER
Institute of Oncology Ljubljana
OTHER