Policlinico "G.B. Rossi", University of Verona, Department of Surgery
Verona, 37134, Italy
NCT Number: NCT01369420
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Verona, 37134, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
90 pulses of 70 microseconds each in duration will be administered per electrode pair.
Other names: ◦ Low Energy Direct Current (LEDC) System, ◦ HVP01 Electroporation System, ◦ NanoKnife LEDC System, ◦ NanoKnife IRE System, ◦ Non-Thermal Irreversible Eletroporation (NTIRE) System, ◦ Angiodynamics IRE System, ◦ Non-Thermal Ablation
Time frame: 90 days
Time frame: 90 days
Evaluation of short term efficacy based upon tumor evaluation and symptomatic response as defined by:
Angiodynamics, Inc.
Industry
A Safety Evaluation of the NanoKnife Low Energy Direct Current (LEDC) System in Subjects With Locally Advanced Unresectable Pancreatic Cancer - A Pilot Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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