NanoKnife Low Energy Direct Current (LEDC) System in Subjects With Locally Advanced Unresectable Pancreatic Cancer
NCT01369420 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2016-11-08
Summary
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.
Conditions
- Pancreatic Adenocarcinoma
Interventions
- DEVICE
-
NanoKnife Low Energy Direct Current (LEDC) System Ablation
90 pulses of 70 microseconds each in duration will be administered per electrode pair.
Sponsors & Collaborators
-
Angiodynamics, Inc.
lead INDUSTRY
Principal Investigators
-
Claudio Bassi, M.D. · Policlinico "G.B. Rossi", University of Verona, Department of Surgery
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-05-31
- Primary Completion
- 2011-12-31
- Completion
- 2012-09-30
Countries
- Italy
Study Locations
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