Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2026-06-20 @ 5:13 PM
Study NCT ID:
NCT03927235
Status:
UNKNOWN
Last Update Posted:
2019-05-30
First Post:
2019-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Different Freezing Time in the Diffuse Parenchymal Lung Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2020-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-28', 'studyFirstSubmitDate': '2019-04-23', 'studyFirstSubmitQcDate': '2019-04-23', 'lastUpdatePostDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnotic yield', 'timeFrame': 'two weeks', 'description': 'Percentage of definitive pathological diagnosis by transbronchial cryobiopsy, the alteration of original diagnosis after transbronchial cryobiopsy'}], 'secondaryOutcomes': [{'measure': 'Complication rate', 'timeFrame': 'one week', 'description': 'Incidence of bleeding, pneumothorax (during the procedure and within 7 days after the intervention) and exacerbations of DPLD related to the transbronchial cryobiopsy'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transbronchial Cryobiopsy', 'freezing time', 'Diagnostic Yield', 'Safety', 'Diffuse Parenchymal Lung Disease'], 'conditions': ['Transbronchial Cryobiopsy', 'Freezing Time', 'Diagnostic Yield', 'Safety']}, 'descriptionModule': {'briefSummary': 'Transbronchial cryobiopsy in different freezing time is performed in patients with undefined diffuse parenchymal lung diseases, and assess the diagnostic yield and safety.', 'detailedDescription': 'Transbronchial cryobiopsy in different freezing time is performed in patients with undefined diffuse parenchymal lung diseases, and assess the diagnostic yield and safety. This is a prospective randomized control trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patients are admitted in the institution as DPLD, while undefined after thorough history collection, laboratory examination and radiological data.\n2. Transbronchial cryobiopsy(TBCB) is indicated by clinicians for definitive diagnosis and patients are content with the examination with agreement signed.\n3. Blood gas analysis, routine blood test, ECG examination, coagulation function, immunological examination, chest HRCT, and liver/kidney function test have been completed.\n\nExclusion Criteria:\n\n1. The radiological data indicates non-DPLD\n2. The clinical examinations mentioned above are not completed.\n3. The patient cannot endure or does not agree the procedure.'}, 'identificationModule': {'nctId': 'NCT03927235', 'briefTitle': 'The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Different Freezing Time in the Diffuse Parenchymal Lung Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Guangzhou Institute of Respiratory Disease'}, 'officialTitle': 'The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Different Freezing Time in the Diffuse Parenchymal Lung Diseases: a Prospective Randomized Control Trial', 'orgStudyIdInfo': {'id': '2018-3-30'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'the freezing time of 3s', 'description': 'Transbronchial cryobiopsy in the freezing time of 3s', 'interventionNames': ['Procedure: Transbronchial Cryobiopsy']}, {'type': 'EXPERIMENTAL', 'label': 'the freezing time of 4s', 'description': 'Transbronchial cryobiopsy in the freezing time of 4s', 'interventionNames': ['Procedure: Transbronchial Cryobiopsy']}, {'type': 'EXPERIMENTAL', 'label': 'the freezing time of 5s', 'description': 'Transbronchial cryobiopsy in the freezing time of 5s', 'interventionNames': ['Procedure: Transbronchial Cryobiopsy']}, {'type': 'EXPERIMENTAL', 'label': 'the freezing time of 6s', 'description': 'Transbronchial cryobiopsy in the freezing time of 6s', 'interventionNames': ['Procedure: Transbronchial Cryobiopsy']}], 'interventions': [{'name': 'Transbronchial Cryobiopsy', 'type': 'PROCEDURE', 'description': 'Transbronchial Cryobiopsy in the Diagnosis of Diffuse Parenchymal Lung Diseases', 'armGroupLabels': ['the freezing time of 3s', 'the freezing time of 4s', 'the freezing time of 5s', 'the freezing time of 6s']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shiyue Li, professor', 'role': 'CONTACT', 'email': 'lishiyue@188.com', 'phone': '13902233925'}, {'name': 'Yao Yao, Dr', 'role': 'CONTACT', 'email': 'yaoyaogy2016@163.com', 'phone': '18826401822'}], 'facility': 'the First Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Xiaobo Chen, master', 'role': 'CONTACT', 'email': 'xiaobo-win@163.com', 'phone': '+8613751721744'}, {'name': 'Shiyue Li, master', 'role': 'CONTACT', 'email': 'lishiyue@188.com', 'phone': '+8613902233925'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangzhou Institute of Respiratory Disease', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the Respiratory department', 'investigatorFullName': 'ShiYue Li', 'investigatorAffiliation': 'Guangzhou Institute of Respiratory Disease'}}}}