Ignite Creation Date:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2025-12-26 @ 3:06 AM
Study NCT ID:
NCT06757920
Status:
COMPLETED
Last Update Posted:
2025-08-28
First Post:
2024-12-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
"Bronchoscopic Argon Plasma Coagulation for Managing Endobronchial Carcinoid Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Argon Plasma Coagulation via non contact probe for debulking and fulgration of the endobronchial carcinoid using fiberoptic bronchoscopy'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-22', 'studyFirstSubmitDate': '2024-12-27', 'studyFirstSubmitQcDate': '2024-12-27', 'lastUpdatePostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dyspnea Borg Scale', 'timeFrame': 'one month', 'description': 'scale from 0 to 4 according to the degree of improvement'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Argon Plasma Coagulation', 'fiberoptic bronchoscopy', 'endobronchial carcinoid'], 'conditions': ['Endobronchial Carcinoid']}, 'referencesModule': {'availIpds': [{'id': 'msabry776@yahoo.com', 'url': 'https://pubmed.ncbi.nlm.nih.gov/17482984/', 'type': 'Study Protocol', 'comment': 'very good'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/23168553/', 'label': 'Successful treatment of endobronchial carcinoid using argon plasma coagulation'}]}, 'descriptionModule': {'briefSummary': 'A small tube will go through the respiratory tract and a non contact cauterization will be done to the inside tumor', 'detailedDescription': 'fiberoptic bronchoscopy will go through the tracheobronchial tree and after localization of the tumor, argon plasma coagulation by initiation non contact electrocautery will be done to the tumor'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1 - Cooperative patient with written informed consent. 2- Patients diagnosed with endobronchial carcinoid. 3- Patients fit for fiberoptic bronchoscopy. 4- Patients unwilling or unfit for surgery.\n\nExclusion Criteria:\n\n1 -Poor karnofsky score. 2- Patients unwilling or unfit for bronchoscopy. 3- Extraluminal lesion. 4- Patients with pacemaker. 5- Forced expiratory volume 1 is less than one litre.'}, 'identificationModule': {'nctId': 'NCT06757920', 'briefTitle': '"Bronchoscopic Argon Plasma Coagulation for Managing Endobronchial Carcinoid Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'The Use of Bronchoscopic Argon Plasma Coagulation in Endobronchial Carcinoid', 'orgStudyIdInfo': {'id': 'FOB - Endobronchial Carcinoid'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'fiberoptic bronchoscopy in one group', 'description': 'fiberoptic bronchoscopic argon plasma coagulation for palliation of endobronchial carc inoid', 'interventionNames': ['Procedure: bronchoscopic argon plasma coagulation']}], 'interventions': [{'name': 'bronchoscopic argon plasma coagulation', 'type': 'PROCEDURE', 'description': 'Argon Plasma Cogulation for Debulking Endobronchial Carcinoid Using Fiberoptic Bronchoscopy', 'armGroupLabels': ['fiberoptic bronchoscopy in one group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11511', 'city': 'Alexandria', 'state': 'Azarita', 'country': 'Egypt', 'facility': 'Chest Department -Faculty of Medicine', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'mohamed sabry eltarhony, lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alexandria University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'because it is against the rules of the chest department'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of chest diseases', 'investigatorFullName': 'Mohamed Sabry', 'investigatorAffiliation': 'Alexandria University'}}}}