Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT06564727
Status:
COMPLETED
Last Update Posted:
2024-08-21
First Post:
2024-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Uniportal VATS Resection for Pulmonary Aspergilloma : Evaluation of Prognostic Factors in a Single Center Experience
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055732', 'term': 'Pulmonary Aspergillosis'}, {'id': 'D013896', 'term': 'Thoracic Diseases'}], 'ancestors': [{'id': 'D001228', 'term': 'Aspergillosis'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008172', 'term': 'Lung Diseases, Fungal'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'study the effect of a treatment and evaluate outcome postoperatively'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2024-08-14', 'studyFirstSubmitQcDate': '2024-08-19', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative complications', 'timeFrame': '30 days', 'description': 'evaluate the complication at 30 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Aspergillosis', 'Surgery-Complications', 'Thoracic Diseases']}, 'descriptionModule': {'briefSummary': 'The objective of this study was to report our experience with U-VATS resection and to evaluate our surgical outcomes with an analysis of postoperative complications. The investigators also estimate the prognostic factors that influence the morbidity and the conversion.', 'detailedDescription': 'Evaluation of prognostic factors Tuberculosis Hemoptysis Type of aspergilloma presence of complete adherence Procedure'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Treatment using uniportal VATS\n\nExclusion Criteria:\n\n\\- Resection using thoracotomy'}, 'identificationModule': {'nctId': 'NCT06564727', 'briefTitle': 'Uniportal VATS Resection for Pulmonary Aspergilloma : Evaluation of Prognostic Factors in a Single Center Experience', 'organization': {'class': 'OTHER', 'fullName': 'Hassan II University'}, 'officialTitle': 'Uniportal VATS Resection for Pulmonary Aspergilloma : Evaluation of Prognostic Factors in a Single Center Experience', 'orgStudyIdInfo': {'id': 'pulmonary aspergilloma'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Uniportal VATS approach', 'description': 'patient treated by Uniportal VATS technique', 'interventionNames': ['Procedure: Uniportal VATS approach']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'VATS resection', 'description': 'patients treated by VATS technique', 'interventionNames': ['Procedure: VATS approach']}], 'interventions': [{'name': 'Uniportal VATS approach', 'type': 'PROCEDURE', 'description': 'Uniportal VATS resection for simple pulmonary aspergilloma', 'armGroupLabels': ['Uniportal VATS approach']}, {'name': 'VATS approach', 'type': 'PROCEDURE', 'description': 'VATS resection for complex pulmonary aspergilloma', 'armGroupLabels': ['VATS resection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20000', 'city': 'Casablanca', 'country': 'Morocco', 'facility': 'Hassan II University', 'geoPoint': {'lat': 33.58831, 'lon': -7.61138}}], 'overallOfficials': [{'name': 'sara WAGUAF', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hassan II University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hassan II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Sara WAGUAF', 'investigatorAffiliation': 'Hassan II University'}}}}