Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-30 @ 5:33 PM
Study NCT ID:
NCT05512533
Status:
COMPLETED
Last Update Posted:
2025-06-05
First Post:
2022-08-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Thin Cp-EBUS Scope BF-UC290F for the Diagnosis of PPLs
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': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-02', 'studyFirstSubmitDate': '2022-08-21', 'studyFirstSubmitQcDate': '2022-08-21', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety Outcome: Complication rate', 'timeFrame': '1 month', 'description': 'The complications refer to the total of serious adverse events related to the procedure during or within 1 month after the operation'}], 'primaryOutcomes': [{'measure': 'Diagnostic yield of BF-UC290F for PPLs', 'timeFrame': 'Up to 6 months', 'description': 'Diagnostic yield is defined as the proportion of peripheral pulmonary lesions (PPLs) diagnosed via endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in all lesions undergoing bronchoscopy biopsy via EBUS-TBNA.'}], 'secondaryOutcomes': [{'measure': 'EBUS scope operation time', 'timeFrame': 'Immediately after each operation', 'description': 'It is defined as the total time from insertion of the EBUS scope to withdrawal of the EBUS scope'}, {'measure': 'The total time of lesion access', 'timeFrame': 'Immediately after Each Operation', 'description': 'It is defined as the total time from the insertion of the EBUS scope to the arrival confirmed by ultrasound image.'}, {'measure': 'Factors affecting the diagnosis rate', 'timeFrame': 'Up to 6 months', 'description': 'Factors affecting the diagnosis rate, including the nature of the lesions, the size of the lesions, the location of the lesions and so on will be analyzed.'}, {'measure': 'The bronchus level of lesions, and the bronchus level reached with the EBUS scope', 'timeFrame': 'During the procedure', 'description': 'Level: Main bronchus is level 0, lobar bronchus is level 1, segment bronchus is level 2, sub-segment bronchus is level 3, and so on, such as: LB3a is level 3'}, {'measure': 'Specimen adequacy', 'timeFrame': 'Up to 6 months', 'description': 'The adequacy of specimens obtained by Thin Convex Probe EBUS Scope BF-UC290F for pathological typing, molecular testing, and immune checkpoint detection'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['EBUS-TBNA', 'diagnostic yield', 'peripheral pulmonary lesions (PPLs)'], 'conditions': ['Peripheral Pulmonary Lesions']}, 'referencesModule': {'references': [{'pmid': '33447457', 'type': 'BACKGROUND', 'citation': 'Zhi X, Wang L, Chen J, Zheng X, Li Y, Sun J. Scoring model of convex probe endobronchial ultrasound multimodal imaging in differentiating benign and malignant lung lesions. J Thorac Dis. 2020 Dec;12(12):7645-7655. doi: 10.21037/jtd-2020-abpd-005.'}, {'pmid': '30610852', 'type': 'BACKGROUND', 'citation': 'Fujino K, Ujiie H, Kinoshita T, Lee CY, Igai H, Inage T, Motooka Y, Gregor A, Suzuki M, Yasufuku K. First Evaluation of the Next-Generation Endobronchial Ultrasound System in Preclinical Models. Ann Thorac Surg. 2019 May;107(5):1464-1471. doi: 10.1016/j.athoracsur.2018.11.068. Epub 2019 Jan 2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the diagnostic value and safety of Thin Convex Probe Endobronchial Ultrasound (TCP-EBUS) Scope for peripheral pulmonary lesions (PPLs)', 'detailedDescription': 'This study will determine the feasibility of the novel thin convex probe endobronchial ultrasound (TCP-EBUS) Scope for the diagnosis of peripheral pulmonary lesions. The primary end point is to clarify the feasibility of using the thin convex probe EBUS scope to biopsy peripheral pulmonary lesions. The secondary objective is to evaluate operation time, sample adequacy, factors affecting the diagnosis rate, etc. The safety, insertion ability, and operability of the thin convex probe EBUS would also be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 18 years old.\n* Chest imaging shows the presence of peripheral pulmonary lesions (surrounded by pulmonary parenchyma and located below the segmental bronchus as seen radiographically.) suspicious of malignancy, 0.8-5cm in greatest diameter in need of bronchoscopic biopsy for clinical purposes, and the investigators consider it possible to be biopsied with BF-UC290F (the bronchus adjacent or leading to the PPLs are close to 5mm in diameter, thus BF-UC290F is able to arrival/access).\n* Patients without contraindications of bronchoscopy.\n* Patients have good medical adherence and signed informed consent.\n\nExclusion Criteria:\n\n* Peripheral pulmonary lesion is pure ground-glass opacity.\n* Visible lumen lesions during bronchoscopy\n* The lesions were adjacent to the central airway (trachea, left and right main bronchus, and right middle bronchus), and the biopsies by the Thin Convex Probe EBUS Scope BF-UC290F were conducted without leaf bronchus entry\n* The investigators believe that patient has other conditions that are not suitable for the study.'}, 'identificationModule': {'nctId': 'NCT05512533', 'briefTitle': 'Feasibility of Thin Cp-EBUS Scope BF-UC290F for the Diagnosis of PPLs', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Chest Hospital'}, 'officialTitle': 'Feasibility and Safety of Thin Convex Probe EBUS Scope BF-UC290F for the Diagnosis of Peripheral Pulmonary Lesions', 'orgStudyIdInfo': {'id': 'SHCHE202208'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BF-UC290F for diagnosing PPLs', 'description': 'Thin EBUS endoscope is inserted and used to visualize peripheral pulmonary lesions, and biopsies will be conducted by EBUS-TBNA.', 'interventionNames': ['Device: Linear Ultrasound Bronchoscope BF-UC290F (Olympus)']}], 'interventions': [{'name': 'Linear Ultrasound Bronchoscope BF-UC290F (Olympus)', 'type': 'DEVICE', 'description': 'A thin Olympus EBUS bronchoscope BF-UC290F will be used for all endobronchial ultrasound examinations, and biopsies will be conducted with EBUS needles - the ViziShot 2 22G (Olympus).', 'armGroupLabels': ['BF-UC290F for diagnosing PPLs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Chest Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Jiayuan Sun, MD., PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Chest Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Chest Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Department of Endoscopy', 'investigatorFullName': 'Jiayuan Sun', 'investigatorAffiliation': 'Shanghai Chest Hospital'}}}}