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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Angiodynamics, Inc.
ClinicalTrials.gov Identifier:
NCT01369420
First received: June 7, 2011
Last updated: March 13, 2012
Last verified: March 2012
History of Changes

June 7, 2011
March 13, 2012
May 2011
December 2011   (final data collection date for primary outcome measure)
Safety [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • 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)
Same as current
Complete list of historical versions of study NCT01369420 on ClinicalTrials.gov Archive Site
Efficacy [ Time Frame: 90 days ] [ Designated as safety issue: No ]

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
Same as current
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Adenocarcinoma
Device: NanoKnife Low Energy Direct Current (LEDC) System Ablation
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
10
May 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. male or female
  2. >/= 18 years of age
  3. meets criteria for locally advanced unresectable pancreatic adenocarcinoma, as radiographically proven pancreatic cancer as determined by a surgical oncologist via pancreatic CT or who were initially thought to be resectable; however at the time of surgery were upstaged to unresectability, via direct visualization
  4. tumor size must be < 4 cm and must be measurable
  5. must have an INR <1.5
  6. must be unresponsive to chemotherapy as demonstrated with either CT or MR imaging and not have taken any chemotherapy agents within 14 days of treatment with the NanoKnife LEDC System
  7. are willing and able to comply with the protocol requirements
  8. are able to comprehend and willing to sign an Informed Consent Form (ICF)

Exclusion Criteria:

  1. a baseline creatinine reported as > 2.0 mg/dL
  2. have any reported baseline lab values with a grade 3 or 4 toxicity as defined by the CTCAE Version 3.0
  3. inability to stop antiplatelet and Coumadin therapy for 7 days prior to and 7 days post treatment with the NanoKnife System
  4. known history of contrast allergy that cannot be medically managed
  5. known hypersensitivity to the metal in the electrodes (stainless steel 304L) that cannot be medically managed
  6. unable to be treated with a muscle blockade agent (e.g. pancuronium bromide, atracurium, cisatracurium, etc)
  7. women who are pregnant or currently breast feeding
  8. women of childbearing potential who are not utilizing an acceptable method of contraception
  9. have taken an investigational agent within 30 days of visit 1
  10. have implanted cardiac pacemakers or defibrillators
  11. have implanted electronic devices or implants with metal parts in the immediate vicinity of a lesion
  12. have a history of epilepsy or cardiac arrhythmia (atrial or ventricular fibrillation)
  13. have a recent history of myocardial infarction (within the past 2 months)
  14. have Q-T intervals greater than 550 ms unless treated with an Accysync Model 72 synchronization system controlling the NanoKnife system's output pulses.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01369420
ONC-208
No
Angiodynamics, Inc.
Angiodynamics, Inc.
Not Provided
Principal Investigator: Claudio Bassi, M.D. Policlinico "G.B. Rossi", University of Verona, Department of Surgery
Angiodynamics, Inc.
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP