Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2026-01-02 @ 1:08 PM
Study NCT ID:
NCT03586050
Status:
COMPLETED
Last Update Posted:
2024-07-24
First Post:
2018-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Safety and Effectiveness of Microwave Ablation in Patients With Hepatocellular Carcinoma in Korea
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jcalia@its.jnj.com', 'phone': '908-808-6380', 'title': 'Jaclyn Calia Stanziola', 'organization': 'ETHICON'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From time of first ablation (Day 0) up to 36 months post ablation', 'description': 'SAF included all participants in whom the microwave ablation procedure was attempted, that is started and regardless of whether it got completed as planned or not.', 'eventGroups': [{'id': 'EG000', 'title': 'Microwave Ablation', 'description': "Participants underwent microwave ablation using the NEUWAVE Certus 140 2.45 Gigahertz (GHz) Ablation System of liver tumors (Hepatocellular Carcinoma \\[HCC\\]) at a single visit, in accordance with their institution's standard-of-care (SOC) for ablation. The treating physician determined the ablation time and power used on a case-by-case basis.", 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 22, 'seriousNumAtRisk': 33, 'deathsNumAffected': 3, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Wound secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Procedural nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dyslipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hepatic infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cerebral artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blood pressure decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Extra nodal marginal zone B-cell lymphoma (MALT type)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Peritonitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hepatocellular carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Whose Ablation Resulted in Technical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Microwave Ablation', 'description': "Participants underwent microwave ablation using the NEUWAVE Certus 140 2.45 Gigahertz (GHz) Ablation System of liver tumors (Hepatocellular Carcinoma \\[HCC\\]) at a single visit, in accordance with their institution's standard-of-care (SOC) for ablation. The treating physician determined the ablation time and power used on a case-by-case basis."}], 'classes': [{'title': 'PI Assessment', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Independent Reviewer Assessment', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post ablation procedure (Day 0) up to 4 days', 'description': 'Number of participants whose ablation resulted in technical success were reported. Technical success was defined as complete tumor ablation with adequate or insufficient margin, based on contrast-enhanced Magnetic resonance imaging (MRI) and Computed scans immediately following the ablation procedure on Day 0 evaluated by the independent reviewer and principle investigator (PI) based on the response to the question "Confirm outcome of ablation".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Whose Ablation Resulted in Primary Technique Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Microwave Ablation', 'description': "Participants underwent microwave ablation using the NEUWAVE Certus 140 2.45 Gigahertz (GHz) Ablation System of liver tumors (Hepatocellular Carcinoma \\[HCC\\]) at a single visit, in accordance with their institution's standard-of-care (SOC) for ablation. The treating physician determined the ablation time and power used on a case-by-case basis."}], 'classes': [{'title': 'PI Assessment', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Independent Reviewer Assessment', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 1 month after the ablation procedure on Day 0', 'description': 'Number of participants whose ablation resulted in primary technique efficacy were reported. Primary technique efficacy was defined as a complete tumor ablation with adequate or insufficient ablation margin, based on contrast-enhanced MRI and CT scans follow-up at 1 month after the ablation procedure, evaluated by the independent reviewer and PI based on the response to the question "Confirm outcome of ablation". The primary technique efficacy was achieved if responses were either "Complete tumor ablation with adequate margin" or "Complete tumor ablation with insufficient margin".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Local Tumor Progression (LTP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Microwave Ablation', 'description': "Participants underwent microwave ablation using the NEUWAVE Certus 140 2.45 Gigahertz (GHz) Ablation System of liver tumors (Hepatocellular Carcinoma \\[HCC\\]) at a single visit, in accordance with their institution's standard-of-care (SOC) for ablation. The treating physician determined the ablation time and power used on a case-by-case basis."}], 'classes': [{'title': 'PI Assessment: 1 Month post ablation', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'PI Assessment: 3 Months post ablation', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'PI Assessment: 6 Months post ablation', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'PI Assessment: 9 Months post ablation', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'PI Assessment: 12 Months post ablation', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'PI Assessment: 18 Months post ablation', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'PI Assessment: 24 Months post ablation', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}]}]}, {'title': 'PI Assessment: 30 Months post ablation', 'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000'}]}]}, {'title': 'PI Assessment: 36 Months post ablation', 'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000'}]}]}, {'title': 'Independent Reviewer: 1 Month post ablation', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Independent Reviewer: 3 Months post ablation', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Independent Reviewer: 6 Months post ablation', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Independent Reviewer: 9 Months post ablation', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Independent Reviewer: 12 Months post ablation', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Independent Reviewer: 18 Months post ablation', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Independent Reviewer: 24 Months post ablation', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}]}]}, {'title': 'Independent Reviewer: 30 Months post ablation', 'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000'}]}]}, {'title': 'Independent Reviewer: 36 Months post ablation', 'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 1, 3, 6, 9, 12, 18, 24, 30 and 36 months post ablation on Day 0', 'description': "Percentage of participants with LTP were reported. The first LTP rate was defined as one minus primary efficacy rate. Primary efficacy rate was defined as percentage of participants with target tumors successfully eradicated following the ablation procedure and measured at each follow-up visit post-ablation. Primary efficacy was achieved when any target tumor had been successfully ablated at the Visit 2 ablation (Technical success achieved) and had no evidence of local tumor progression (LTP) based on the independent reviewer's assessment and PI assessment.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Primary Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Microwave Ablation', 'description': "Participants underwent microwave ablation using the NEUWAVE Certus 140 2.45 Gigahertz (GHz) Ablation System of liver tumors (Hepatocellular Carcinoma \\[HCC\\]) at a single visit, in accordance with their institution's standard-of-care (SOC) for ablation. The treating physician determined the ablation time and power used on a case-by-case basis."}], 'classes': [{'title': 'PI Assessment: 1 Month post ablation', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'PI Assessment: 3 Months post ablation', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'PI Assessment: 6 Months post ablation', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'PI Assessment: 9 Months post ablation', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'PI Assessment: 12 Months post ablation', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'PI Assessment: 18 Months post ablation', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'PI Assessment: 24 Months post ablation', 'categories': [{'measurements': [{'value': '96.4', 'groupId': 'OG000'}]}]}, {'title': 'PI Assessment: 30 Months post ablation', 'categories': [{'measurements': [{'value': '92.4', 'groupId': 'OG000'}]}]}, {'title': 'PI Assessment: 36 Months post ablation', 'categories': [{'measurements': [{'value': '92.4', 'groupId': 'OG000'}]}]}, {'title': 'Independent Reviewer: 1 Month post ablation', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Independent Reviewer: 3 Months post ablation', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Independent Reviewer: 6 Months post ablation', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Independent Reviewer: 9 Months post ablation', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Independent Reviewer: 12 Months post ablation', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Independent Reviewer: 18 Months post ablation', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Independent Reviewer: 24 Months post ablation', 'categories': [{'measurements': [{'value': '96.4', 'groupId': 'OG000'}]}]}, {'title': 'Independent Reviewer: 30 Months post ablation', 'categories': [{'measurements': [{'value': '92.7', 'groupId': 'OG000'}]}]}, {'title': 'Independent Reviewer: 36 Months post ablation', 'categories': [{'measurements': [{'value': '92.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 1, 3, 6, 9, 12, 18, 24, 30 and 36 months post ablation on Day 0', 'description': "Percentage of participants with primary efficacy based on the independent reviewer and PI assessment were reported. Primary efficacy rate was defined as percentage of participants with target tumors successfully eradicated following the ablation procedure and measured at each follow-up visit post-ablation. Primary efficacy was achieved when any target tumor had been successfully ablated at the Visit 2 ablation (Technical success achieved) and had no evidence of LTP based on the independent reviewer's assessment and PI assessment.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Secondary Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Microwave Ablation', 'description': "Participants underwent microwave ablation using the NEUWAVE Certus 140 2.45 Gigahertz (GHz) Ablation System of liver tumors (Hepatocellular Carcinoma \\[HCC\\]) at a single visit, in accordance with their institution's standard-of-care (SOC) for ablation. The treating physician determined the ablation time and power used on a case-by-case basis."}], 'classes': [{'title': 'PI Assessment'}, {'title': 'Independent Reviewer Assessment'}], 'timeFrame': 'From time of first ablation (Day 0) up to 36 months', 'description': 'Percentage of participants with secondary efficacy based on the independent reviewer and PI assessment were reported. Secondary efficacy rate was defined as percentage of participants with target tumors that had undergone successful repeat ablation following identification of local tumor progression.', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy. Data for this outcome measure was not collected and analyzed as no participant had undergone repeat ablations.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Microwave Ablation', 'description': "Participants underwent microwave ablation using the NEUWAVE Certus 140 2.45 Gigahertz (GHz) Ablation System of liver tumors (Hepatocellular Carcinoma \\[HCC\\]) at a single visit, in accordance with their institution's standard-of-care (SOC) for ablation. The treating physician determined the ablation time and power used on a case-by-case basis."}], 'classes': [{'title': 'PI Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.8', 'groupId': 'OG000'}]}]}, {'title': 'Independent Reviewer Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 36 months after the ablation procedure on Day 0', 'description': "PFS rate was defined as the percentage of participants with PFS. PFS was defined as the time from the first ablation until LTP (first LTP rate was defined as one minus primary efficacy rate), any identification of a new (nontarget) lesion/tumor during follow-up, or death due to any cause (whichever occurs first). PFS rate based on independent reviewer's assessment and PI assessment was reported.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy. Here "N" (number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure and "n"(number analyzed) signifies the number of participants analyzed for specified categories.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Microwave Ablation', 'description': "Participants underwent microwave ablation using the NEUWAVE Certus 140 2.45 Gigahertz (GHz) Ablation System of liver tumors (Hepatocellular Carcinoma \\[HCC\\]) at a single visit, in accordance with their institution's standard-of-care (SOC) for ablation. The treating physician determined the ablation time and power used on a case-by-case basis."}], 'classes': [{'categories': [{'measurements': [{'value': '90.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 36 months after the ablation procedure on Day 0', 'description': 'OS rate was defined as the percentage of participants with OS. OS was defined as the time from the first ablation until death due to any cause.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events (AEs) Within 3 Months Post Ablation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Microwave Ablation', 'description': "Participants underwent microwave ablation using the NEUWAVE Certus 140 2.45 Gigahertz (GHz) Ablation System of liver tumors (Hepatocellular Carcinoma \\[HCC\\]) at a single visit, in accordance with their institution's standard-of-care (SOC) for ablation. The treating physician determined the ablation time and power used on a case-by-case basis."}], 'classes': [{'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From time of first ablation (Day 0) up to 3 months post ablation', 'description': 'Percentage of participants with AEs within 3 months post ablation were reported. An AE was an untoward medical occurrence (sign, symptom or disease) in a participant, and which did not necessarily have a causal relationship with the study medical device.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set (SAF) included all participants in whom the microwave ablation procedure was attempted, that is, started and regardless of whether it got completed as planned or not.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events Within 36 Months Post Ablation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Microwave Ablation', 'description': "Participants underwent microwave ablation using the NEUWAVE Certus 140 2.45 Gigahertz (GHz) Ablation System of liver tumors (Hepatocellular Carcinoma \\[HCC\\]) at a single visit, in accordance with their institution's standard-of-care (SOC) for ablation. The treating physician determined the ablation time and power used on a case-by-case basis."}], 'classes': [{'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From time of first ablation (Day 0) up to 36 months post ablation', 'description': 'Percentage of participants with AEs within 36 months post ablation were reported. An AE was an untoward medical occurrence (sign, symptom or disease) in a participant, and which did not necessarily have a causal relationship with the study medical device.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF included all participants in whom the microwave ablation procedure was attempted, that is, started and regardless of whether it got completed as planned or not.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Visual Analogue Scale (VAS) Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Microwave Ablation', 'description': "Participants underwent microwave ablation using the NEUWAVE Certus 140 2.45 Gigahertz (GHz) Ablation System of liver tumors (Hepatocellular Carcinoma \\[HCC\\]) at a single visit, in accordance with their institution's standard-of-care (SOC) for ablation. The treating physician determined the ablation time and power used on a case-by-case basis."}], 'classes': [{'title': 'Post ablation (Day 0)', 'categories': [{'measurements': [{'value': '0.32', 'spread': '0.258', 'groupId': 'OG000'}]}]}, {'title': '1 Month post ablation', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.194', 'groupId': 'OG000'}]}]}, {'title': '3 Months post ablation', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.204', 'groupId': 'OG000'}]}]}, {'title': '6 Months post ablation', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.214', 'groupId': 'OG000'}]}]}, {'title': '9 Months post ablation', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.211', 'groupId': 'OG000'}]}]}, {'title': '12 Months post ablation', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.176', 'groupId': 'OG000'}]}]}, {'title': '18 Months post ablation', 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.145', 'groupId': 'OG000'}]}]}, {'title': '24 Months post ablation', 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.148', 'groupId': 'OG000'}]}]}, {'title': '30 Months post ablation', 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.121', 'groupId': 'OG000'}]}]}, {'title': '36 Months post ablation', 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.180', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-Ablation), Day 0 (post ablation), Months 1, 3, 6, 9, 12, 18, 24, 30 and 36 (post ablation on Day 0)', 'description': 'Change from baseline in VAS pain scores were reported. VAS pain score was a self-reported pain score on a 100 millimeter (mm) scale which ranged from ranged from 0 mm (no pain) to 100 mm (severe pain). Higher score indicated severe pain. Baseline was defined as the last non-missing measurement taken prior to date of first microwave ablation (including unscheduled assessments) or on the date of first microwave ablation but prior to the time of first probe placement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Microwave Ablation', 'description': "Participants underwent microwave ablation using the NEUWAVE Certus 140 2.45 Gigahertz (GHz) Ablation System of liver tumors (Hepatocellular Carcinoma \\[HCC\\]) at a single visit, in accordance with their institution's standard-of-care (SOC) for ablation. The treating physician determined the ablation time and power used on a case-by-case basis."}], 'classes': [{'title': '1 Month post ablation', 'categories': [{'measurements': [{'value': '1.23', 'spread': '11.415', 'groupId': 'OG000'}]}]}, {'title': '3 Months post ablation', 'categories': [{'measurements': [{'value': '-0.05', 'spread': '11.120', 'groupId': 'OG000'}]}]}, {'title': '6 Months post ablation', 'categories': [{'measurements': [{'value': '-0.42', 'spread': '14.147', 'groupId': 'OG000'}]}]}, {'title': '9 Months post ablation', 'categories': [{'measurements': [{'value': '0.74', 'spread': '14.427', 'groupId': 'OG000'}]}]}, {'title': '12 Months post ablation', 'categories': [{'measurements': [{'value': '2.23', 'spread': '9.526', 'groupId': 'OG000'}]}]}, {'title': '18 Months post ablation', 'categories': [{'measurements': [{'value': '3.38', 'spread': '13.608', 'groupId': 'OG000'}]}]}, {'title': '24 Months post ablation', 'categories': [{'measurements': [{'value': '1.59', 'spread': '15.425', 'groupId': 'OG000'}]}]}, {'title': '30 Months post ablation', 'categories': [{'measurements': [{'value': '4.01', 'spread': '11.652', 'groupId': 'OG000'}]}]}, {'title': '36 Months post ablation', 'categories': [{'measurements': [{'value': '2.47', 'spread': '13.793', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-Ablation), Months 1, 3, 6, 9, 12, 18, 24, 30 and 36 (post ablation on Day 0)', 'description': 'Change from baseline in EORTC QLQ-C30 scale score were reported. EORTC QLQ-C30 contains 30 questions for assessing overall health in cancer patients. The questions reflect how patients felt during the past week and are scored 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) except for the last two questions, which are scored on a 7-point Likert Scale from 1-7 (1=very poor to 7=excellent). All the questions were transformed to a 0-100 scale and summed for an overall quality of life score, with a high score representing higher quality of life. Baseline: last non-missing measurement prior to date of first microwave ablation or on date of first microwave ablation but prior to time of first probe placement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EORTC QLQ HCC 18 Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Microwave Ablation', 'description': "Participants underwent microwave ablation using the NEUWAVE Certus 140 2.45 Gigahertz (GHz) Ablation System of liver tumors (Hepatocellular Carcinoma \\[HCC\\]) at a single visit, in accordance with their institution's standard-of-care (SOC) for ablation. The treating physician determined the ablation time and power used on a case-by-case basis."}], 'classes': [{'title': '1 Month post ablation', 'categories': [{'measurements': [{'value': '1.58', 'spread': '10.397', 'groupId': 'OG000'}]}]}, {'title': '3 Months post ablation', 'categories': [{'measurements': [{'value': '1.85', 'spread': '9.663', 'groupId': 'OG000'}]}]}, {'title': '6 Months post ablation', 'categories': [{'measurements': [{'value': '0.69', 'spread': '9.575', 'groupId': 'OG000'}]}]}, {'title': '9 Months post ablation', 'categories': [{'measurements': [{'value': '1.36', 'spread': '12.508', 'groupId': 'OG000'}]}]}, {'title': '12 Months post ablation', 'categories': [{'measurements': [{'value': '1.11', 'spread': '8.902', 'groupId': 'OG000'}]}]}, {'title': '18 Months post ablation', 'categories': [{'measurements': [{'value': '3.24', 'spread': '13.080', 'groupId': 'OG000'}]}]}, {'title': '24 Months post ablation', 'categories': [{'measurements': [{'value': '0.41', 'spread': '13.593', 'groupId': 'OG000'}]}]}, {'title': '30 Months post ablation', 'categories': [{'measurements': [{'value': '-1.57', 'spread': '10.948', 'groupId': 'OG000'}]}]}, {'title': '36 Months post ablation', 'categories': [{'measurements': [{'value': '-4.33', 'spread': '14.320', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-Ablation), Months 1, 3, 6, 9, 12, 18, 24, 30 and 36 (post ablation on Day 0)', 'description': 'Change from baseline in EORTC QLQ HCC 18 scale score were reported. EORTC 18-item hepatocellular cancer health-related quality of life questionnaire (QLQ-HCC18) was an 18-multi-item scales which were grouped into 8 symptom scales such as fatigue, body image, jaundice, nutrition, pain, fever, abdominal swelling and sex life. All scales were grouped and converted to scores of 0 to 100 according to the scoring manual; a higher score represented a more severe symptom or problem. Baseline was defined as the last non-missing measurement taken prior to date of first microwave ablation (including unscheduled assessments) or on the date of first microwave ablation but prior to the time of first probe placement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy.'}, {'type': 'SECONDARY', 'title': 'Health Economics: Complete Procedure Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Microwave Ablation', 'description': "Participants underwent microwave ablation using the NEUWAVE Certus 140 2.45 Gigahertz (GHz) Ablation System of liver tumors (Hepatocellular Carcinoma \\[HCC\\]) at a single visit, in accordance with their institution's standard-of-care (SOC) for ablation. The treating physician determined the ablation time and power used on a case-by-case basis."}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '46.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 0 (On day of ablation treatment)', 'description': 'Complete procedure time was defined as the time between the first probe placement and the last probe removal.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy.'}, {'type': 'SECONDARY', 'title': 'Health Economics: Total Ablation Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Microwave Ablation', 'description': "Participants underwent microwave ablation using the NEUWAVE Certus 140 2.45 Gigahertz (GHz) Ablation System of liver tumors (Hepatocellular Carcinoma \\[HCC\\]) at a single visit, in accordance with their institution's standard-of-care (SOC) for ablation. The treating physician determined the ablation time and power used on a case-by-case basis."}], 'classes': [{'categories': [{'measurements': [{'value': '7.76', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '16.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 0 (On the day of ablation treatment)', 'description': 'Total ablation duration were reported.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy.'}, {'type': 'SECONDARY', 'title': 'Health Economics: Median Number of Ablations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Microwave Ablation', 'description': "Participants underwent microwave ablation using the NEUWAVE Certus 140 2.45 Gigahertz (GHz) Ablation System of liver tumors (Hepatocellular Carcinoma \\[HCC\\]) at a single visit, in accordance with their institution's standard-of-care (SOC) for ablation. The treating physician determined the ablation time and power used on a case-by-case basis."}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 0 (On the day of ablation treatment)', 'description': 'The median number of ablations was reported.', 'unitOfMeasure': 'ablations', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy.'}, {'type': 'SECONDARY', 'title': 'Health Economics: Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Microwave Ablation', 'description': "Participants underwent microwave ablation using the NEUWAVE Certus 140 2.45 Gigahertz (GHz) Ablation System of liver tumors (Hepatocellular Carcinoma \\[HCC\\]) at a single visit, in accordance with their institution's standard-of-care (SOC) for ablation. The treating physician determined the ablation time and power used on a case-by-case basis."}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '22'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 0 (On day of ablation treatment) up to 30 days (1-month post ablation visit)', 'description': 'Length of hospital stay were reported. Length of hospital stay was defined as the time from procedure completion to hospital discharge.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy.'}, {'type': 'SECONDARY', 'title': 'Health Economics: Percentage of Participants With Single and Multi Probes Usage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Microwave Ablation', 'description': "Participants underwent microwave ablation using the NEUWAVE Certus 140 2.45 Gigahertz (GHz) Ablation System of liver tumors (Hepatocellular Carcinoma \\[HCC\\]) at a single visit, in accordance with their institution's standard-of-care (SOC) for ablation. The treating physician determined the ablation time and power used on a case-by-case basis."}], 'classes': [{'title': 'Single probe', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}]}]}, {'title': 'Multi probe', 'categories': [{'measurements': [{'value': '96.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 (On the day of ablation treatment)', 'description': 'Percentage of participants with single and multiple probes usage were reported. PR and LK probes were used at least once.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Microwave Ablation', 'description': "Participants underwent microwave ablation using the NEUWAVE Certus 140 2.45 Gigahertz (GHz) Ablation System of liver tumors (Hepatocellular Carcinoma \\[HCC\\]) at a single visit, in accordance with their institution's standard-of-care (SOC) for ablation. The treating physician determined the ablation time and power used on a case-by-case basis."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'Full Analysis Set (FAS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Recruitment occurred from 04Dec2017 through 21May2020.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Microwave Ablation', 'description': "Participants underwent microwave ablation using the NEUWAVE Certus 140 2.45 Gigahertz (GHz) Ablation System of liver tumors (Hepatocellular Carcinoma \\[HCC\\]) at a single visit, in accordance with their institution's standard-of-care (SOC) for ablation. The treating physician determined the ablation time and power used on a case-by-case basis."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.6', 'spread': '8.16', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Age of participant at the time of informed consent', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Maximum Tumor Dimension', 'classes': [{'categories': [{'measurements': [{'value': '2.49', 'spread': '0.578', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Centimeters (cm)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Liver Segment', 'classes': [{'title': 'Segment 3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Segment 4', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Segment 5', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Segment 6', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Segment 7', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Segment 8', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Location of the tumor in the liver (multiple could be selected)', 'unitOfMeasure': 'Participants'}, {'title': 'Tumor Depth', 'classes': [{'title': 'Superficial', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}, {'title': 'Deep', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Dome', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Major Vessel/Duct Assessment', 'classes': [{'title': 'Near Major Vessel/Duct', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'No Major Vessel/Duct Near Ablation', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Location of the tumor/ablation in relation to a major vessel/duct', 'unitOfMeasure': 'Participants'}, {'title': 'BCLC (Barcelona Clinic Liver Cancer) Staging', 'classes': [{'title': '0 (Very early stage disease; Child-Pugh score of A, ECOG 0-1, single tumor < 2cm)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'A (Early stage disease; Child-Pugh score of A/B, ECOG 0-1, single or 2-3 tumors < 3cm)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}, {'title': 'B (Intermediate stage disease; Child-Pugh score of A/B, ECOG 0-1, multinodular tumors)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'C (Advanced stage disease; Child-Pugh score of A/B, ECOG 0-2, portal vein invasion)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'D (Terminal disease; Child-Pugh score C, ECOG>2, metastasized tumors to lymph nodes or other organs)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "All participants were confirmed to have BCLC staging of Stage A within 5 weeks prior to the day of ablation based on imaging and biopsy confirmation in accordance with their institution Standard of Care (SOC). The BCLC staging system is validated and widely accepted as it offers the most prognostic information (that is, includes information on tumor size/burden, liver function, and participant's Eastern Cooperative Oncology Group \\[ECOG\\] performance status). BCLC stages include 0, A, B, C and D.", 'unitOfMeasure': 'Participants'}, {'title': 'Child-Pugh Score', 'classes': [{'title': 'Class A (mild liver disease; 5-6 points)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}, {'title': 'Class B (moderately severe liver disease; 7-9 points)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Class C (severe liver disease; 10-15 points)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'All participants were confirmed to have functional hepatic reserve based on the Child-Pugh score (Class A or Class B) within 5 weeks prior to the day of ablation. Child-Pugh Scores assess the prognosis of liver disease. Five clinical features are assessed and assigned 1-3 points depending on severity (1 being none, 2 being mild, and 3 being severe): encephalopathy, presence of ascites, bilirubin blood level, albumin blood level, and prothrombin time prolongation. Classes A, B, and C are based on the total number of points.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-19', 'size': 613379, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-04-30T13:00', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-27', 'studyFirstSubmitDate': '2018-02-08', 'resultsFirstSubmitDate': '2021-05-03', 'studyFirstSubmitQcDate': '2018-07-12', 'lastUpdatePostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-29', 'studyFirstPostDateStruct': {'date': '2018-07-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Whose Ablation Resulted in Technical Success', 'timeFrame': 'Post ablation procedure (Day 0) up to 4 days', 'description': 'Number of participants whose ablation resulted in technical success were reported. Technical success was defined as complete tumor ablation with adequate or insufficient margin, based on contrast-enhanced Magnetic resonance imaging (MRI) and Computed scans immediately following the ablation procedure on Day 0 evaluated by the independent reviewer and principle investigator (PI) based on the response to the question "Confirm outcome of ablation".'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Whose Ablation Resulted in Primary Technique Efficacy', 'timeFrame': 'At 1 month after the ablation procedure on Day 0', 'description': 'Number of participants whose ablation resulted in primary technique efficacy were reported. Primary technique efficacy was defined as a complete tumor ablation with adequate or insufficient ablation margin, based on contrast-enhanced MRI and CT scans follow-up at 1 month after the ablation procedure, evaluated by the independent reviewer and PI based on the response to the question "Confirm outcome of ablation". The primary technique efficacy was achieved if responses were either "Complete tumor ablation with adequate margin" or "Complete tumor ablation with insufficient margin".'}, {'measure': 'Percentage of Participants With Local Tumor Progression (LTP)', 'timeFrame': 'At 1, 3, 6, 9, 12, 18, 24, 30 and 36 months post ablation on Day 0', 'description': "Percentage of participants with LTP were reported. The first LTP rate was defined as one minus primary efficacy rate. Primary efficacy rate was defined as percentage of participants with target tumors successfully eradicated following the ablation procedure and measured at each follow-up visit post-ablation. Primary efficacy was achieved when any target tumor had been successfully ablated at the Visit 2 ablation (Technical success achieved) and had no evidence of local tumor progression (LTP) based on the independent reviewer's assessment and PI assessment."}, {'measure': 'Percentage of Participants With Primary Efficacy', 'timeFrame': 'At 1, 3, 6, 9, 12, 18, 24, 30 and 36 months post ablation on Day 0', 'description': "Percentage of participants with primary efficacy based on the independent reviewer and PI assessment were reported. Primary efficacy rate was defined as percentage of participants with target tumors successfully eradicated following the ablation procedure and measured at each follow-up visit post-ablation. Primary efficacy was achieved when any target tumor had been successfully ablated at the Visit 2 ablation (Technical success achieved) and had no evidence of LTP based on the independent reviewer's assessment and PI assessment."}, {'measure': 'Percentage of Participants With Secondary Efficacy', 'timeFrame': 'From time of first ablation (Day 0) up to 36 months', 'description': 'Percentage of participants with secondary efficacy based on the independent reviewer and PI assessment were reported. Secondary efficacy rate was defined as percentage of participants with target tumors that had undergone successful repeat ablation following identification of local tumor progression.'}, {'measure': 'Progression Free Survival (PFS) Rate', 'timeFrame': 'At 36 months after the ablation procedure on Day 0', 'description': "PFS rate was defined as the percentage of participants with PFS. PFS was defined as the time from the first ablation until LTP (first LTP rate was defined as one minus primary efficacy rate), any identification of a new (nontarget) lesion/tumor during follow-up, or death due to any cause (whichever occurs first). PFS rate based on independent reviewer's assessment and PI assessment was reported."}, {'measure': 'Overall Survival (OS) Rate', 'timeFrame': 'At 36 months after the ablation procedure on Day 0', 'description': 'OS rate was defined as the percentage of participants with OS. OS was defined as the time from the first ablation until death due to any cause.'}, {'measure': 'Percentage of Participants With Adverse Events (AEs) Within 3 Months Post Ablation', 'timeFrame': 'From time of first ablation (Day 0) up to 3 months post ablation', 'description': 'Percentage of participants with AEs within 3 months post ablation were reported. An AE was an untoward medical occurrence (sign, symptom or disease) in a participant, and which did not necessarily have a causal relationship with the study medical device.'}, {'measure': 'Percentage of Participants With Adverse Events Within 36 Months Post Ablation', 'timeFrame': 'From time of first ablation (Day 0) up to 36 months post ablation', 'description': 'Percentage of participants with AEs within 36 months post ablation were reported. An AE was an untoward medical occurrence (sign, symptom or disease) in a participant, and which did not necessarily have a causal relationship with the study medical device.'}, {'measure': 'Change From Baseline in Visual Analogue Scale (VAS) Pain Score', 'timeFrame': 'Baseline (Pre-Ablation), Day 0 (post ablation), Months 1, 3, 6, 9, 12, 18, 24, 30 and 36 (post ablation on Day 0)', 'description': 'Change from baseline in VAS pain scores were reported. VAS pain score was a self-reported pain score on a 100 millimeter (mm) scale which ranged from ranged from 0 mm (no pain) to 100 mm (severe pain). Higher score indicated severe pain. Baseline was defined as the last non-missing measurement taken prior to date of first microwave ablation (including unscheduled assessments) or on the date of first microwave ablation but prior to the time of first probe placement.'}, {'measure': 'Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 Scale Score', 'timeFrame': 'Baseline (Pre-Ablation), Months 1, 3, 6, 9, 12, 18, 24, 30 and 36 (post ablation on Day 0)', 'description': 'Change from baseline in EORTC QLQ-C30 scale score were reported. EORTC QLQ-C30 contains 30 questions for assessing overall health in cancer patients. The questions reflect how patients felt during the past week and are scored 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) except for the last two questions, which are scored on a 7-point Likert Scale from 1-7 (1=very poor to 7=excellent). All the questions were transformed to a 0-100 scale and summed for an overall quality of life score, with a high score representing higher quality of life. Baseline: last non-missing measurement prior to date of first microwave ablation or on date of first microwave ablation but prior to time of first probe placement.'}, {'measure': 'Change From Baseline in EORTC QLQ HCC 18 Scale Score', 'timeFrame': 'Baseline (Pre-Ablation), Months 1, 3, 6, 9, 12, 18, 24, 30 and 36 (post ablation on Day 0)', 'description': 'Change from baseline in EORTC QLQ HCC 18 scale score were reported. EORTC 18-item hepatocellular cancer health-related quality of life questionnaire (QLQ-HCC18) was an 18-multi-item scales which were grouped into 8 symptom scales such as fatigue, body image, jaundice, nutrition, pain, fever, abdominal swelling and sex life. All scales were grouped and converted to scores of 0 to 100 according to the scoring manual; a higher score represented a more severe symptom or problem. Baseline was defined as the last non-missing measurement taken prior to date of first microwave ablation (including unscheduled assessments) or on the date of first microwave ablation but prior to the time of first probe placement.'}, {'measure': 'Health Economics: Complete Procedure Time', 'timeFrame': 'Day 0 (On day of ablation treatment)', 'description': 'Complete procedure time was defined as the time between the first probe placement and the last probe removal.'}, {'measure': 'Health Economics: Total Ablation Duration', 'timeFrame': 'Day 0 (On the day of ablation treatment)', 'description': 'Total ablation duration were reported.'}, {'measure': 'Health Economics: Median Number of Ablations', 'timeFrame': 'Day 0 (On the day of ablation treatment)', 'description': 'The median number of ablations was reported.'}, {'measure': 'Health Economics: Length of Hospital Stay', 'timeFrame': 'Day 0 (On day of ablation treatment) up to 30 days (1-month post ablation visit)', 'description': 'Length of hospital stay were reported. Length of hospital stay was defined as the time from procedure completion to hospital discharge.'}, {'measure': 'Health Economics: Percentage of Participants With Single and Multi Probes Usage', 'timeFrame': 'Day 0 (On the day of ablation treatment)', 'description': 'Percentage of participants with single and multiple probes usage were reported. PR and LK probes were used at least once.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Hepatocellular Carcinoma; liver cancer; cancer; liver'], 'conditions': ['Carcinoma, Hepatocellular', 'Hepatocellular Carcinoma', 'Hepatocellular Cancer', 'Cancer, Hepatocellular']}, 'descriptionModule': {'briefSummary': 'This is a single arm, non-randomized, single center study to evaluate ablation, oncologic outcomes and safety in the treatment of hepatocellular carcinoma.', 'detailedDescription': 'This prospective, single-arm single center study will provide clinical data for the Neuwave Medical Microwave Ablation System and accessories.\n\nIndividuals who undergo microwave ablation of liver tumors who meet study entry criteria, will be enrolled.\n\nThe enrollment for the study will continue until 30 eligible subjects complete the 3-month visit after ablation for the primary effectiveness and safety analysis.\n\nThe subjects will be followed for approximately up to 36 months after the ablation procedure for safety, oncologic and ablation outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Confirmed hepatocellular carcinoma, tumor size of more than 2 cm and up to 5cm, single location, Barcelona Clinic Liver Cancer (BCLC) Stage A based on imaging and biopsy confirmation\n2. Primary hepatocellular carcinoma or recurrent hepatocellular carcinoma which was previously treated with ablation or surgical resection only;\n3. Scheduled for microwave ablation of the liver;\n4. Performance status 0-1 (Eastern Cooperative Oncology Group classification);\n5. Functional hepatic reserve based on the Child-Pugh score (Class A or B);\n6. American Society of Anesthesiologists (ASA) score \\< 3;\n7. Given voluntary, written informed consent to participate in this study and has authorized the transfer of his/her information to the Sponsor, and willing to comply with study-related evaluation and treatment schedule;\n8. At least 19 years of age\n\nExclusion Criteria:\n\n1. Active bacterial infection or fungal infection;\n2. Systemic administration of steroids, including herbal supplements that contain steroids, within 30 days prior to the study procedure;\n3. Chemotherapy or radiation therapy for hepatocellular carcinoma may not be performed for 30 days prior to the study procedure;\n4. Subject with implantable pacemakers or other electronic implants;\n5. Planned/ scheduled liver surgery.\n6. Subject with a platelet count of less than 20,000/mm3;\n7. Subject with an INR greater than 1.5;\n8. Subject with renal failure on renal dialysis;\n9. Scheduled concurrent procedure other than microwave ablation in the liver;\n10. Pregnant or lactating;\n11. Physical or psychological condition which would impair study participation;\n12. Participation in any other clinical study concurrently or within the last 3 months;\n13. The subject is judged unsuitable for study participation by the Investigator for any other reason;\n14. Unable or unwilling to attend follow-up visits and examinations.'}, 'identificationModule': {'nctId': 'NCT03586050', 'briefTitle': 'Study to Evaluate the Safety and Effectiveness of Microwave Ablation in Patients With Hepatocellular Carcinoma in Korea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ethicon, Inc.'}, 'officialTitle': 'A Study to Evaluate the Safety and Effectiveness of Microwave Ablation in Patients With Hepatocellular Carcinoma in Korea', 'orgStudyIdInfo': {'id': 'NEU_2017_01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Microwave Ablation', 'description': 'All patients will receive microwave ablation using the NeuWave Microwave Ablation System and Accessories', 'interventionNames': ['Device: Microwave ablation']}], 'interventions': [{'name': 'Microwave ablation', 'type': 'DEVICE', 'description': 'All patients will receive microwave ablation using the NeuWave Microwave Ablation System and Accessories', 'armGroupLabels': ['Microwave Ablation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Hyunchul Rhim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ethicon, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}