NCT01369420

NanoKnife Low Energy Direct Current (LEDC) System in Subjects With Locally Advanced Unresectable Pancreatic Cancer

A Safety Evaluation of the NanoKnife Low Energy Direct Current (LEDC) System in Subjects With Locally Advanced Unresectable Pancreatic Cancer - A Pilot Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Angiodynamics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	NanoKnife Low Energy Direct Current (LEDC) System Ablation	90 pulses of 70 microseconds each in duration will be administered per electrode pair.

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-12-01
• Completion: 2012-09-01
• First posted: 2011-06-09
• Last updated: 2016-11-08

Locations

1 site across 1 country: Italy