Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2026-02-06 @ 12:17 AM
Study NCT ID:
NCT06935695
Status:
RECRUITING
Last Update Posted:
2025-04-20
First Post:
2025-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surveillance Versus Bronchoscopy After Airway Stenting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001999', 'term': 'Bronchoscopy'}], 'ancestors': [{'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013510', 'term': 'Pulmonary Surgical Procedures'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-11', 'studyFirstSubmitDate': '2025-04-04', 'studyFirstSubmitQcDate': '2025-04-11', 'lastUpdatePostDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of stent-related complications warranting an intervention', 'timeFrame': '3 months after enrollment', 'description': 'Possible complications:\n\nStent migration, biofilm formation, obstructive mucus plugging, obstructive granulation requiring intervention'}], 'secondaryOutcomes': [{'measure': 'Number of unscheduled visits due to stent-related complications', 'timeFrame': '3 months after enrollment', 'description': 'Number of unscheduled visits due to stent-related complications'}, {'measure': 'Number of urgent care or emergency room visits due to stent-related complications', 'timeFrame': '3 months after enrollment', 'description': 'Number of urgent care or emergency room visits due to stent-related complications'}, {'measure': 'Number of hospitalizations due to stent-related complications', 'timeFrame': '3 months after enrollment', 'description': 'Number of hospitalizations due to stent-related complications'}, {'measure': 'Number of stent-related complications as detected during a bronchoscopy or on cross-sectional imaging', 'timeFrame': '3 months after enrollment', 'description': 'Number of stent-related complications as detected during a bronchoscopy or on cross-sectional imaging'}, {'measure': 'Protocol Feasibility Composite Score', 'timeFrame': '3 months after enrollment', 'description': 'A composite score comprised from recruitment success (enrollment of target participant numbers), protocol adherence, data completeness, intervention safety, and resource availability to measure protocol feasibility. The total scale for the composite score is 1 to 5, with higher score indicating more feasibility.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Airway', 'Stent', 'Bronchoscopy', 'Surveillance'], 'conditions': ['Bronchial Stents']}, 'descriptionModule': {'briefSummary': 'Randomized, pilot study that evaluates surveillance bronchoscopy versus no surveillance for patients that undergo tracheobronchial stenting'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All adult patients that undergo central airway (trachea, main stem bronchi and bronchus intermedius) stenting.\n\nExclusion Criteria:\n\n* Inability to obtain informed consent due to cognitive, neurologic or psychiatric impairment.\n* Lobar or segmental stents alone\n* Terminally ill patients considered too sick to undergo a follow-up surveillance bronchoscopy\n* Stent insertion as a trial for excessive central airway collapse (as the duration of these stents is only 1-2 weeks)\n* Patients with a tracheostomy (as these patients can undergo frequent in-line suctioning that can affect the outcomes being assessed)'}, 'identificationModule': {'nctId': 'NCT06935695', 'acronym': 'SCOPE-IT', 'briefTitle': 'Surveillance Versus Bronchoscopy After Airway Stenting', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Surveillance Versus Prn bronChOscoPy aftEr aIrway stenTing (SCOPE-IT)', 'orgStudyIdInfo': {'id': 'STUDY-24-01352'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Surveillance Group', 'description': 'Patients will be scheduled to undergo a surveillance bronchoscopy 4-6 weeks after the stent insertion.', 'interventionNames': ['Device: Bronchoscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No Surveillance', 'description': 'Patients will only undergo bronchoscopies if warranted by clinical symptoms deemed to be secondary to stent-related complications.', 'interventionNames': ['Device: Bronchoscopy']}], 'interventions': [{'name': 'Bronchoscopy', 'type': 'DEVICE', 'otherNames': ['PRN bronchoscopy'], 'description': 'Bronchoscopy is a procedure that uses a bronchoscope (a thin, tube-like instrument with a light and a lens for viewing) to examine the inside of the trachea, bronchi (air passages that lead to the lungs), and lungs. The bronchoscope is inserted through the nose or mouth.', 'armGroupLabels': ['No Surveillance', 'Surveillance Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Axel Duval, MD', 'role': 'CONTACT', 'email': 'axel.duval@mountsinai.org'}, {'name': 'Udit Chaddha, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Mount Sinai Health System', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Axel Duval, MD', 'role': 'CONTACT', 'email': 'axel.duval@mountsinai.org', 'phone': '\u202d(212) 824-8546\u202c'}], 'overallOfficials': [{'name': 'Udit Chaddha, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).', 'accessCriteria': "Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose.\n\nFor individual participant data meta-analysis. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in Mount Sinai's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (to be determined)."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Udit Chaddha', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}