The purpose of this study is to evaluate the safety and feasibility of the NanoKnife Low Energy Direct Current (LEDC) System when used to treat unresectable pancreatic adenocarcinoma. Safety will be reviewed by means of analysis of adverse events, including serious adverse events, laboratory data, physician exam findings, and vital signs.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
90 pulses of 70 microseconds each in duration will be administered per electrode pair.
Policlinico "G.B. Rossi", University of Verona, Department of Surgery
Verona, Verona, Italy
Safety
* reported adverse events and adverse effects/events (serious and non serious), * unanticipated adverse events and device complaints, * safety laboratory tests (hematology, chemistry, amylase, lipase), * vital signs, * physical findings (including symptoms, vital signs and weight changes)
Time frame: 90 days
Efficacy
Evaluation of short term efficacy based upon tumor evaluation and symptomatic response as defined by: * imaging will be used to evaluate changes in tumor size in addition to evaluating the completeness of ablation, * tumor evaluation by evaluating changes in CA-19-9 marker, * symptomatic changes of quality of life questionnaires, * physician assessment of the performance status of the subject, * pain assessment and subject analgesic consumption, * assessment of tumor for downstaging to resectability at the time of imaging
Time frame: 90 days
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