Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2026-04-16 @ 8:23 AM
Study NCT ID:
NCT02425059
Status:
COMPLETED
Last Update Posted:
2021-09-05
First Post:
2015-04-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Irreversible Electroporation(IRE) For Unresectable Rectal Neoplasms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018274', 'term': 'Electroporation'}], 'ancestors': [{'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D055664', 'term': 'Electrochemical Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-01', 'studyFirstSubmitDate': '2015-04-15', 'studyFirstSubmitQcDate': '2015-04-22', 'lastUpdatePostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'A minimum and maximum range of voltage for safe and effective IRE', 'timeFrame': '3 months', 'description': 'A minimum and maximum range of voltage for safe and effective IRE will be analyzed for optimal choice.'}, {'measure': 'Progress free disease (PFS)', 'timeFrame': '12 months'}, {'measure': 'Overall survival (OS)', 'timeFrame': '36 mouths', 'description': 'Patients will be followed for 36 months after IRE for OS analyzed.'}], 'primaryOutcomes': [{'measure': 'Number of participants with Adverse events', 'timeFrame': '6 month'}], 'secondaryOutcomes': [{'measure': 'Percentage of lesions that show no sign of recurrence 12 months after IRE', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['irreversible electroporation', 'Unresectable Rectal Neoplasms'], 'conditions': ['Rectal Neoplasms']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Rectal Neoplasms.', 'detailedDescription': 'By enrolling patients with unresectable Rectal Neoplasms adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for unresectable Rectal Neoplasms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Rectal Neoplasms diagnosed by positive biopsy or non-invasive criteria,\n* Not suitable for surgical resection,\n* Eastern Cooperative Oncology Group (ECOG) score of 0-1,\n* A prothrombin time ratio \\> 50%,\n* Platelet count \\> 80x10\\^9/L,\n* Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,\n* Able to comprehend and willing to sign the written informed consent form (ICF),\n* Have a life expectancy of at least 3 months.\n\nExclusion Criteria:\n\n* Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,\n* Any active implanted device (eg Pacemaker),\n* Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,\n* Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,\n* Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.'}, 'identificationModule': {'nctId': 'NCT02425059', 'briefTitle': 'Irreversible Electroporation(IRE) For Unresectable Rectal Neoplasms', 'organization': {'class': 'OTHER', 'fullName': 'Fuda Cancer Hospital, Guangzhou'}, 'officialTitle': 'Irreversible Electroporation(IRE) For Unresectable Rectal Neoplasms: Phase I and Phase II Clinical Trial', 'orgStudyIdInfo': {'id': 'Rectal cancer-IRE-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IRE Group', 'description': 'irreversible electroporation for Unresectable Rectal Neoplasms', 'interventionNames': ['Procedure: Irreversible electroporation (IRE)', 'Device: NanoKnife']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The patients without treatment'}], 'interventions': [{'name': 'Irreversible electroporation (IRE)', 'type': 'PROCEDURE', 'description': 'Irreversible Electroportion For Unresectable Rectal Neoplasms guide with ultrasound or/and CT.', 'armGroupLabels': ['IRE Group']}, {'name': 'NanoKnife', 'type': 'DEVICE', 'armGroupLabels': ['IRE Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Biological treatment center in Fuda cancer hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Lizhi Niu, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fuda Cancer Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fuda Cancer Hospital, Guangzhou', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}