Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Pancreatic Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

90 pulses of 70 microseconds each in duration will be administered per electrode pair.

NanoKnife Low Energy Direct Current (LEDC) System Ablation

Claudio Bassi, M.D.

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.

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

* 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)

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

Angiodynamics, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
NanoKnife Low Energy Direct Current (LEDC) System in Subjects With Locally Advanced Unresectable Pancreatic Cancer	NCT01369420	Pancreatic Aden...	NanoKnife Low E...	18 Years -	Angiodynamics, Inc.
NanoKnife Low Energy Direct Current (LEDC) System in Subjects With Locally Advanced Unresectable Pancreatic Cancer	NCT01369420	Pancreatic Aden...	NanoKnife Low E...	18 Years -	Angiodynamics, Inc.

Spots Global Cancer Trial Database for non thermal ablation