Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-01-07 @ 6:47 AM
Study NCT ID:
NCT06530667
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-31
First Post:
2024-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Broadband Collaborative Pulse Ablation Instrument Treating Malignant Pulmonary Nodules
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-26', 'studyFirstSubmitDate': '2024-07-22', 'studyFirstSubmitQcDate': '2024-07-26', 'lastUpdatePostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ablation success rate', 'timeFrame': '1 month after ablation', 'description': 'Ablation success rate = (numbers of nodule be completely ablated) / (numbers of nodule be ablated). Contrast-enhanced CT examination showed no significant enhancement of the nodule ablation area, and the nodule was considered to be completely ablated.'}], 'secondaryOutcomes': [{'measure': 'Nodule ablation time', 'timeFrame': 'Immediately after ablation', 'description': 'The time taken for nodule ablation is recorded according to the time displayed by the ablation instrument'}, {'measure': 'Complete ablation rate', 'timeFrame': '3 months after ablation', 'description': 'Ablation success rate = (numbers of nodule be completely ablated) / (numbers of nodule be ablated). Contrast-enhanced CT examination showed no significant enhancement of the nodule ablation area, and the nodule was considered to be completely ablated'}, {'measure': 'Nodule recurrence rate', 'timeFrame': '6 months after ablation', 'description': 'Ablation recurrence rate = (numbers of nodule recurrence) / (numbers of nodule be ablated). Contrast-enhanced CT showed the presence of an enhancement foci within the area of nodule ablation, and the nodule was considered to be recurrence.'}, {'measure': 'Adverse events', 'timeFrame': 'Up to 6 months', 'description': 'Adverse Events as assessed by NCI CTCAE V5.0 (Safety and Tolerability)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Neoplasm Malignant', 'Secondary Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Effectiveness safety and feasibility of the broadband collaborative pulse ablation instrument in treating malignant pulmonary nodules', 'detailedDescription': 'This clinical trial is to observe the safety and efficacy of the broadband synergistic pulse ablation device for treating malignant pulmonary nodules, and to provide reference data for the development of formal trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age: between 18 and 70 years old with no gender limitation;\n2. Malignant pulmonary nodules diagnosed by cytology and/or histopathology, or the number of tumors ≤3. The pulmonary nodules were oligometastatic and the primary lesions were stable, with no uncontrolled metastasis to other sites;\n3. Surgery is not available or the patient refuses surgical treatment;\n4. Nodules' Maximum diameter≤2cm;\n5. ECOG score≤2;\n6. Patients understood the trial procedure and voluntarily signed informed consent.\n\nExclusion Criteria:\n\n1. An electronic device is implanted near the target area or an implanted pacemaker or defibrillator is present in the body;\n2. Coagulation dysfunction with severe bleeding tendency and short-term correction (prothrombin time \\>18s, prothrombin activity \\<40%, platelet \\<80×109 /L);\n3. Patient who can not stop taking Antiplatelet and anticoagulant drugs 5 days before surgery;\n4. Severe pulmonary fibrosis and pulmonary hypertension;\n5. Patients with poor control of pleural effusion;\n6. Patients with serious insufficiency of Liver, kidney, heart, lung, and brain function;\n7. Patients with Severe anemia, dehydration, and severe disturbance of nutrient metabolism, which cannot be corrected or improved in the short term;\n8. Patients with severe systemic infection, high fever (\\>38.5℃);\n9. Pregnant and lactating women and those planning to become pregnant within one year;\n10. Participants in clinical trials of any drugs and/or medical devices within 3 months before enrollment;\n11. Any other factors that the investigator considers inappropriate for inclusion or that may affect the subject's participation in the study."}, 'identificationModule': {'nctId': 'NCT06530667', 'briefTitle': 'Broadband Collaborative Pulse Ablation Instrument Treating Malignant Pulmonary Nodules', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'A Prospective Clinic Study to Evaluate the Effectiveness Safety and Feasibility of the Broadband Collaborative Pulse Ablation Instrument in Treating Malignant Pulmonary Nodules', 'orgStudyIdInfo': {'id': 'ZS-IR-110R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment group', 'description': 'Patients treated by broadband collaborative pulse ablation', 'interventionNames': ['Device: broadband collaborative pulse ablation']}], 'interventions': [{'name': 'broadband collaborative pulse ablation', 'type': 'DEVICE', 'description': 'Via CT guided, patients with malignant pulmonary nodules would be treated by broadband collaborative pulse ablation', 'armGroupLabels': ['treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Lingxiao Liu', 'role': 'CONTACT', 'email': 'w_feihang@163.com', 'phone': '+86-18616881019'}, {'name': 'Lingxiao Liu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhongshan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Lingxiao Liu', 'role': 'CONTACT', 'email': 'liulingxiao2022@163.com', 'phone': '+86-18616881019'}], 'overallOfficials': [{'name': 'Lingxiao Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}