Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2025-12-27 @ 9:37 PM
Study NCT ID:
NCT04885595
Status:
COMPLETED
Last Update Posted:
2024-06-28
First Post:
2021-04-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnosis of Peripheral Lung Nodules Using Cryobiopsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-27', 'studyFirstSubmitDate': '2021-04-18', 'studyFirstSubmitQcDate': '2021-05-08', 'lastUpdatePostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic yield', 'timeFrame': 'up to 1 month', 'description': 'The diagnostic yield of the malign lesions that we were able to visualise with EBUS in percentage'}], 'secondaryOutcomes': [{'measure': 'Size of harvested tissue in millimeter', 'timeFrame': 'up to 1 month', 'description': 'The biopsies are assessed for total size in millimeter'}, {'measure': 'Size of malign tissue in millimeter', 'timeFrame': 'up to 1 month', 'description': 'The biopsies are assessed for size of malign tissue in milimeter'}, {'measure': 'Occurrence of bleeding events', 'timeFrame': 'up to 1 month', 'description': 'Occurrence of bleeding events'}, {'measure': 'Size of artifact-free alvoelar space in percentage', 'timeFrame': 'up to 1 month', 'description': 'Size of artifact-free alvoelar space in percentage'}, {'measure': 'Radial endobronchial utrasound probe orientation (excentric, concentric, adjacent)', 'timeFrame': '1 day', 'description': 'Lesion orientation with regards of the radial endobronchial ultrasound probe'}, {'measure': 'Occurence of pneumothorax', 'timeFrame': 'up to 1 month', 'description': 'Detection with X-ray'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cryobiopsy'], 'conditions': ['Lung; Node']}, 'descriptionModule': {'briefSummary': 'Since the traditional radial endobronchial ultrasound guided biopsy technique of solitary pulmonary nodules using the forceps has several shortcomings, the purpose of this study is to investigate a new biopsy technique using the transbronchial cryobrobe', 'detailedDescription': 'This is a prospective randomized trial to assess diagnostic accuracy and safety of cryobiopsy using two different outer diameters. Included patients are 1:1 randomized to receive forceps biopsy following cryobiopsy with a 1.1mm or 1.7mm cryoprobe.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Solitary pulmonary nodule with indication of bronchoscopic diagnostic approach\n* Age between 18 and 90 years\n* Written informed consent after participant's information\n\nExclusion Criteria:\n\n* Age \\< 18 and \\> 90 years\n* Lacking ability to form an informed consent (including impaired judgement, communi-cation barriers)\n* Contraindication against bronchoscopy (e.g. co-morbidities)\n* INR \\> 2 or Thrombocytes \\< 50000\n* Double antiplatelet drugs (e.g. ASS and Clopidogrel) within 7 days before biopsy\n* Anticoagulation with NOAK within 48 hours before biopsy\n* Moderate or severe pulmonary hypertension (mPAP \\> 30 mmHg, RV/RA \\>30 mmHg)\n* Tumors suspicious of endobronchial growth"}, 'identificationModule': {'nctId': 'NCT04885595', 'acronym': 'Cryo-Nodule', 'briefTitle': 'Diagnosis of Peripheral Lung Nodules Using Cryobiopsy', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Bronchoscopic Diagnosis of Peripheral Lung Nodules Using Endobronchial Ultrasound Guided Forceps and Cryobiopsy. A Randomized-controlled Trial', 'orgStudyIdInfo': {'id': '2021-00323'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Forceps-Cryo 1.1 mm', 'description': 'Forceps biopsy following cryobiopsy with a 1.1mm cryoprobe are obtained within the same session', 'interventionNames': ['Procedure: Forceps biopsy and cryobiopsy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Forceps-Cryo 1.7 mm', 'description': 'Forceps biopsy following cryobiopsy with a 1.7mm cryoprobe are obtained within the same session', 'interventionNames': ['Procedure: Forceps biopsy and cryobiopsy']}], 'interventions': [{'name': 'Forceps biopsy and cryobiopsy', 'type': 'PROCEDURE', 'description': 'Once the nodule is visualized by radial EBUS, the position of the probe in relation to the lesion is noted. Routinely, forceps biopsy and cryobiopsy are used serially in each patient within the same session.', 'armGroupLabels': ['Forceps-Cryo 1.1 mm', 'Forceps-Cryo 1.7 mm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Carolin Steinack, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Carolin Steinack', 'investigatorAffiliation': 'University of Zurich'}}}}