Ignite Creation Date:
2025-12-25 @ 1:01 AM
Ignite Modification Date:
2026-01-03 @ 9:21 PM
Study NCT ID:
NCT05046093
Status:
COMPLETED
Last Update Posted:
2025-06-03
First Post:
2021-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Outcomes of Cryobiopsy for Peripheral Pulmonary Lesions - A Prospective Pilot Study
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': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2023-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-28', 'studyFirstSubmitDate': '2021-08-18', 'studyFirstSubmitQcDate': '2021-09-14', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Type of bronchoscope', 'timeFrame': 'up to 1 day', 'description': 'Type of bronchoscope used is assessed as the following scale (a. thin; b. ultrathin).'}, {'measure': 'Guide sheath use', 'timeFrame': 'up to 1 day', 'description': 'Guide sheath use is assessed as the following scale (a. yes; b. no).'}, {'measure': 'Radial endobronchial ultrasound probe orientation', 'timeFrame': 'up to 1 day', 'description': 'Lesion orientation regarding radial endobronchial ultrasound probe is assessed as the following scale (a. within, concentric; b. within, eccentric; c. adjacent; d. invisible).'}, {'measure': 'Procedure time in minutes and seconds', 'timeFrame': 'up to 1 day', 'description': 'The time spent in procedure begins with the insertion of bronchoscope into vocal cord and ends with removal of bronchoscope from vocal cord.'}, {'measure': 'Diameter of cryoprobe', 'timeFrame': 'up to 1 day', 'description': 'Diameter of cryoprobe use is assessed as the following scale (a. 1.1mm; b. 1.7mm).'}, {'measure': 'Number of biopsy', 'timeFrame': 'up to 1 day', 'description': 'The number of biopsy samples is assessed.'}, {'measure': 'Freezing time of cryoprobe in seconds', 'timeFrame': 'up to 1 day', 'description': 'The freezing time of cryoprobe for sampling the lesions is assessed in seconds.'}, {'measure': 'Biopsy size in millimeter', 'timeFrame': 'up to 1 month', 'description': 'Size of biopsy tissue is assessed by pathologist for maximum and minimum diameter in millimeter.'}], 'primaryOutcomes': [{'measure': 'Diagnostic yield based on pathologic diagnosis', 'timeFrame': 'up to 6 months', 'description': 'Diagnostic yield based on pathologic diagnosis is defined as percentage of definitive pathological diagnosis by transbronchial cryobiopsy. If the bronchoscopic procedure fails to diagnose malignancy, the gold standard will be the results of additional procedures such as repeated bronchoscopic biopsy, percutaneous needle aspiration, surgical biopsy, or CT follow-up without any invasive procedure.'}], 'secondaryOutcomes': [{'measure': 'Diagnostic yield based on clinical diagnosis', 'timeFrame': 'up to 6 months', 'description': 'Diagnostic yield based on clinical diagnosis is defined as percentage of pathological diagnosis with suspicious results by transbronchial cryobiopsy. If the bronchoscopic procedure fails to diagnose malignancy, the gold standard will be the results of additional procedures such as repeated bronchoscopic biopsy, percutaneous needle aspiration, surgical biopsy, or CT follow-up without any invasive procedure.'}, {'measure': 'Adverse events', 'timeFrame': 'up to 1 week', 'description': 'Occurrence of bleeding, pneumothorax, and infection events (during the procedure and within 1 week after the intervention). Bleeding will be assessed as the following scale (a. mild = self-limiting bleeding, manageable with suction alone and without the need for any specific intervention; b. moderate = use of any additional intervention such as instillation of ice-cold saline or vasoconstrictive drugs, transient balloon tamponade, or therapeutic bronchoscope (external diameter 6mm); c. severe = additional prolonged monitoring or intensive care therapy after the procedure or if the bleeding was fatal). Pneumothorax will be assessed as the following scale (a. pneumothorax not requiring chest tube insertion; b. pneumothorax requiring chest tube insertion).'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cryobiopsy', 'Pulmonary nodule', 'Radial EBUS'], 'conditions': ['Lung Nodule']}, 'referencesModule': {'references': [{'pmid': '37380091', 'type': 'DERIVED', 'citation': 'Kim SH, Mok J, Kim S, Yoo WH, Jo EJ, Kim MH, Lee K, Kim KU, Park HK, Lee MK, Eom JS. Clinical outcomes of transbronchial cryobiopsy using a 1.1-mm diameter cryoprobe for peripheral lung lesions - A prospective pilot study. Respir Med. 2023 Oct;217:107338. doi: 10.1016/j.rmed.2023.107338. Epub 2023 Jun 26.'}]}, 'descriptionModule': {'briefSummary': 'As the former radial endobronchial ultrasound (R-EBUS) guided transbronchial forcep biopsy of peripheral pulmonary nodules has some limitations, the purpose of this study is to investigate a novel biopsy technique, transbronchial cryobiopsy, in patients with peripheral pulmonary nodules.', 'detailedDescription': 'This is a prospective, single arm, open label trial to assess the diagnostic accuracy and safety of the transbronchial cryobiopsy in patients with peripheral pulmonary nodule using a 1.1mm cryoprobe, combined with bronchoscope (with/without guide sheath), R-EBUS, virtual bronchoscopy navigation, and fluoroscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient with peripheral lung nodule less than 30mm on CT scan referred for biopsy\n* Age ≥ 18\n* Written informed consent after participant's information\n\nExclusion Criteria:\n\n* Central lesion (visible on bronchoscope) or presence of metastatic lymph node (not requiring radial EBUS)\n* Pure GGO lesion\n* Patients at increased risk of bleeding\n\n 1. Cannot stop agents such as antiplatelet agent or anticoagulant therapy\n 2. Coagulopathy: Thrombocytopenia (\\< 100,000/mm3) or prolonged PT (INR \\> 1.5)\n* Patient with existing or risk of pulmonary and cardiovascular decompensation\n* Intolerance to sedation\n* Vulnerable groups such as pregnant woman, breast feeding, etc.\n* Previously diagnosed cancer patient who needs re-biopsy for genetic susceptibility"}, 'identificationModule': {'nctId': 'NCT05046093', 'briefTitle': 'Clinical Outcomes of Cryobiopsy for Peripheral Pulmonary Lesions - A Prospective Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Pusan National University Hospital'}, 'officialTitle': 'Clinical Outcomes of Cryobiopsy for Peripheral Pulmonary Lesions - A Prospective Pilot Study', 'orgStudyIdInfo': {'id': '2105-045-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single intervention arm - transbronchial cryobiopsy', 'description': 'Patients enrolled in this single arm will have lung nodules biopsied by transbronchial cryobiopsy.', 'interventionNames': ['Diagnostic Test: Transbronchial cryobiopsy']}], 'interventions': [{'name': 'Transbronchial cryobiopsy', 'type': 'DIAGNOSTIC_TEST', 'description': 'When the lung nodule is visualized by thin bronchoscope (4mm) with R-EBUS, cryobiopsy is performed. If not visualized, ultrathin (3mm) bronchoscope is used.\n\nCryobiopsy is performed with 1.1mm cryo-probe.', 'armGroupLabels': ['Single intervention arm - transbronchial cryobiopsy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49241', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Pusan National University hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}], 'overallOfficials': [{'name': 'Jung Seop Eom, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pusan National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pusan National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}