Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT01369420
Status:
COMPLETED
Last Update Posted:
2016-11-08
First Post:
2011-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
NanoKnife Low Energy Direct Current (LEDC) System in Subjects With Locally Advanced Unresectable Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016503', 'term': 'Drug Delivery Systems'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-07', 'studyFirstSubmitDate': '2011-06-07', 'studyFirstSubmitQcDate': '2011-06-08', 'lastUpdatePostDateStruct': {'date': '2016-11-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': '90 days', 'description': '* reported adverse events and adverse effects/events (serious and non serious),\n* unanticipated adverse events and device complaints,\n* safety laboratory tests (hematology, chemistry, amylase, lipase),\n* vital signs,\n* physical findings (including symptoms, vital signs and weight changes)'}], 'secondaryOutcomes': [{'measure': 'Efficacy', 'timeFrame': '90 days', 'description': 'Evaluation of short term efficacy based upon tumor evaluation and symptomatic response as defined by:\n\n* imaging will be used to evaluate changes in tumor size in addition to evaluating the completeness of ablation,\n* tumor evaluation by evaluating changes in CA-19-9 marker,\n* symptomatic changes of quality of life questionnaires,\n* physician assessment of the performance status of the subject,\n* pain assessment and subject analgesic consumption,\n* assessment of tumor for downstaging to resectability at the time of imaging'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['locoregional cancer therapy', 'pancreatic cancer', 'unresectable pancreatic cancer', 'pancreatic adenocarcinoma', 'locally advanced, unresectable pancreatic cancer', 'pancreatic cancer tumor ablation', 'NanoKnife tumor ablation for pancreatic cancer', 'NanoKnife LEDC system tumor ablation', 'Non thermal ablation', 'Irreversible electroporation for pancreatic cancer treatment', 'IRE for unresectable pancreatic cancer'], 'conditions': ['Pancreatic Adenocarcinoma']}, 'referencesModule': {'references': [{'pmid': '16407624', 'type': 'BACKGROUND', 'citation': 'Varshney S, Sewkani A, Sharma S, Kapoor S, Naik S, Sharma A, Patel K. Radiofrequency ablation of unresectable pancreatic carcinoma: feasibility, efficacy and safety. JOP. 2006 Jan 11;7(1):74-8.'}, {'pmid': '17089173', 'type': 'BACKGROUND', 'citation': 'Spiliotis JD, Datsis AC, Michalopoulos NV, Kekelos SP, Vaxevanidou A, Rogdakis AG, Christopoulou AN. Radiofrequency ablation combined with palliative surgery may prolong survival of patients with advanced cancer of the pancreas. Langenbecks Arch Surg. 2007 Jan;392(1):55-60. doi: 10.1007/s00423-006-0098-5. Epub 2006 Nov 7.'}, {'pmid': '18333241', 'type': 'BACKGROUND', 'citation': 'Hadjicostas P, Malakounides N, Varianos C, Kitiris E, Lerni F, Symeonides P. Radiofrequency ablation in pancreatic cancer. HPB (Oxford). 2006;8(1):61-4. doi: 10.1080/13651820500466673.'}, {'pmid': '16967436', 'type': 'BACKGROUND', 'citation': 'Wu Y, Tang Z, Fang H, Gao S, Chen J, Wang Y, Yan H. High operative risk of cool-tip radiofrequency ablation for unresectable pancreatic head cancer. J Surg Oncol. 2006 Oct 1;94(5):392-5. doi: 10.1002/jso.20580.'}, {'pmid': '10630378', 'type': 'BACKGROUND', 'citation': 'Matsui Y, Nakagawa A, Kamiyama Y, Yamamoto K, Kubo N, Nakase Y. Selective thermocoagulation of unresectable pancreatic cancers by using radiofrequency capacitive heating. Pancreas. 2000 Jan;20(1):14-20. doi: 10.1097/00006676-200001000-00002.'}, {'pmid': '14736529', 'type': 'BACKGROUND', 'citation': 'Elias D, Baton O, Sideris L, Lasser P, Pocard M. Necrotizing pancreatitis after radiofrequency destruction of pancreatic tumours. Eur J Surg Oncol. 2004 Feb;30(1):85-7. doi: 10.1016/j.ejso.2003.10.013.'}, {'pmid': '16868477', 'type': 'BACKGROUND', 'citation': 'Connor S, Raraty MG, Neoptolemos JP, Layer P, Runzi M, Steinberg WM, Barkin JS, Bradley EL 3rd, Dimagno E. Does infected pancreatic necrosis require immediate or emergency debridement? Pancreas. 2006 Aug;33(2):128-34. doi: 10.1097/01.mpa.0000234074.76501.a6. No abstract available.'}, {'pmid': '15191686', 'type': 'BACKGROUND', 'citation': 'Raraty MG, Connor S, Criddle DN, Sutton R, Neoptolemos JP. Acute pancreatitis and organ failure: pathophysiology, natural history, and management strategies. Curr Gastroenterol Rep. 2004 Apr;6(2):99-103. doi: 10.1007/s11894-004-0035-0.'}, {'pmid': '17198179', 'type': 'BACKGROUND', 'citation': 'Chan YC, Leung PS. Acute pancreatitis: animal models and recent advances in basic research. Pancreas. 2007 Jan;34(1):1-14. doi: 10.1097/01.mpa.0000246658.38375.04.'}, {'pmid': '16534248', 'type': 'BACKGROUND', 'citation': 'Freitag M, Standl TG, Kleinhans H, Gottschalk A, Mann O, Rempf C, Bachmann K, Gocht A, Petri S, Izbicki JR, Strate T. Improvement of impaired microcirculation and tissue oxygenation by hemodilution with hydroxyethyl starch plus cell-free hemoglobin in acute porcine pancreatitis. Pancreatology. 2006;6(3):232-9. doi: 10.1159/000091962. Epub 2006 Mar 9.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. male or female\n2. \\>/= 18 years of age\n3. 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\n4. tumor size must be \\< 4 cm and must be measurable\n5. must have an INR \\<1.5\n6. 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\n7. are willing and able to comply with the protocol requirements\n8. are able to comprehend and willing to sign an Informed Consent Form (ICF)\n\nExclusion Criteria:\n\n1. a baseline creatinine reported as \\> 2.0 mg/dL\n2. have any reported baseline lab values with a grade 3 or 4 toxicity as defined by the CTCAE Version 3.0\n3. inability to stop antiplatelet and Coumadin therapy for 7 days prior to and 7 days post treatment with the NanoKnife System\n4. known history of contrast allergy that cannot be medically managed\n5. known hypersensitivity to the metal in the electrodes (stainless steel 304L) that cannot be medically managed\n6. unable to be treated with a muscle blockade agent (e.g. pancuronium bromide, atracurium, cisatracurium, etc)\n7. women who are pregnant or currently breast feeding\n8. women of childbearing potential who are not utilizing an acceptable method of contraception\n9. have taken an investigational agent within 30 days of visit 1\n10. have implanted cardiac pacemakers or defibrillators\n11. have implanted electronic devices or implants with metal parts in the immediate vicinity of a lesion\n12. have a history of epilepsy or cardiac arrhythmia (atrial or ventricular fibrillation)\n13. have a recent history of myocardial infarction (within the past 2 months)\n14. have Q-T intervals greater than 550 ms unless treated with an Accysync Model 72 synchronization system controlling the NanoKnife system's output pulses."}, 'identificationModule': {'nctId': 'NCT01369420', 'briefTitle': 'NanoKnife Low Energy Direct Current (LEDC) System in Subjects With Locally Advanced Unresectable Pancreatic Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Angiodynamics, Inc.'}, 'officialTitle': 'A Safety Evaluation of the NanoKnife Low Energy Direct Current (LEDC) System in Subjects With Locally Advanced Unresectable Pancreatic Cancer - A Pilot Study', 'orgStudyIdInfo': {'id': 'ONC-208'}}, 'armsInterventionsModule': {'interventions': [{'name': 'NanoKnife Low Energy Direct Current (LEDC) System Ablation', 'type': 'DEVICE', 'otherNames': ['◦ 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'], 'description': '90 pulses of 70 microseconds each in duration will be administered per electrode pair.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '37134', 'city': 'Verona', 'state': 'Verona', 'country': 'Italy', 'facility': 'Policlinico "G.B. Rossi", University of Verona, Department of Surgery', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}], 'overallOfficials': [{'name': 'Claudio Bassi, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Policlinico "G.B. Rossi", University of Verona, Department of Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Angiodynamics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}