Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT01221493
Status:
UNKNOWN
Last Update Posted:
2010-10-15
First Post:
2010-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EBUS Guided Cryo Biopsy of Solitary Pulmonary Nodules
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003074', 'term': 'Solitary Pulmonary Nodule'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-10-14', 'studyFirstSubmitDate': '2010-10-14', 'studyFirstSubmitQcDate': '2010-10-14', 'lastUpdatePostDateStruct': {'date': '2010-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': '24 h after intervention', 'description': 'Number of Participants with Adverse Events as a Measure of Safety Detailed analysis of number of Pneumothoraces and number of bleeding complication'}], 'secondaryOutcomes': [{'measure': 'Efficacy', 'timeFrame': '48 h after intervention', 'description': 'Diagnostic yield of the different biopsy techniques in establishing a specific diagnosis of the lesion'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['solitary pulmonary nodules', 'transbronchial lung biopsy', 'endobronchial ultrasound'], 'conditions': ['Yield of Cryo Biopsy in Lung Cancer', 'Solitary Pulmonary Nodule']}, 'referencesModule': {'references': [{'pmid': '20802352', 'type': 'BACKGROUND', 'citation': 'Eberhardt R, Kahn N, Gompelmann D, Schumann M, Heussel CP, Herth FJ. LungPoint--a new approach to peripheral lesions. J Thorac Oncol. 2010 Oct;5(10):1559-63. doi: 10.1097/JTO.0b013e3181e8b308.'}, {'pmid': '20477337', 'type': 'BACKGROUND', 'citation': 'Eberhardt R, Gompelmann D, Herth FJ. Electromagnetic navigation in lung cancer: research update. Expert Rev Respir Med. 2009 Oct;3(5):469-73. doi: 10.1586/ers.09.36.'}, {'pmid': '19648733', 'type': 'BACKGROUND', 'citation': 'Eberhardt R, Morgan RK, Ernst A, Beyer T, Herth FJ. Comparison of suction catheter versus forceps biopsy for sampling of solitary pulmonary nodules guided by electromagnetic navigational bronchoscopy. Respiration. 2010;79(1):54-60. doi: 10.1159/000232394. Epub 2009 Jul 31.'}, {'pmid': '20203535', 'type': 'BACKGROUND', 'citation': "Eberhardt R, Kahn N, Herth FJ. 'Heat and destroy': bronchoscopic-guided therapy of peripheral lung lesions. Respiration. 2010;79(4):265-73. doi: 10.1159/000284015. Epub 2010 Feb 10."}, {'pmid': '23900983', 'type': 'DERIVED', 'citation': 'Schuhmann M, Bostanci K, Bugalho A, Warth A, Schnabel PA, Herth FJ, Eberhardt R. Endobronchial ultrasound-guided cryobiopsies in peripheral pulmonary lesions: a feasibility study. Eur Respir J. 2014 Jan;43(1):233-9. doi: 10.1183/09031936.00011313. Epub 2013 Jul 30.'}]}, 'descriptionModule': {'briefSummary': 'To proof the feasibility and safety of EBUS guided transbronchial cryo biopsies in peripheral lung lesions', 'detailedDescription': 'Solitary pulmonary nodule are a diagnostic dilemma. Nowadays not only the basic tissue diagnosis is necessary, molecular signals are state of the art. Therefore more tissue is necessary. With a cryoprobe the amount of tissue is increased compared to the classical forceps biopsy.\n\nUntil now, the use of the cryoprobe ism´t show in peripheral lung tissue.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* solitary pulmonary nodule \\< 4 cm\n* no endobronchial lesion\n* indication for bronchoscopy\n\nExclusion Criteria:\n\n* coagulopathy\n* pulmonary hypertension\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT01221493', 'briefTitle': 'EBUS Guided Cryo Biopsy of Solitary Pulmonary Nodules', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'orgStudyIdInfo': {'id': 'S-320'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cryo biospy', 'interventionNames': ['Procedure: Cryo biopsy']}], 'interventions': [{'name': 'Cryo biopsy', 'type': 'PROCEDURE', 'otherNames': ['Cryo biopsy probe 20416-032, ERBE company, Germany'], 'description': 'Cryoprobe, Erbe Company', 'armGroupLabels': ['Cryo biospy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69190', 'city': 'Heidelberg', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Felix JF Herth, MD, PhD', 'role': 'CONTACT', 'email': 'felix.herth@thoraxklinik-heidelberg.de', 'phone': '+49 6221 396', 'phoneExt': '1200'}, {'name': 'Felix JF Herth, MD, Phd', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ralf Eberhardt, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Pneumology and Critical Care medicine', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'centralContacts': [{'name': 'Felix JF Herth, MD, PhD', 'role': 'CONTACT', 'email': 'felix.herth@thoraxklinik-heidelberg.de', 'phone': '+49-6221 396', 'phoneExt': '1200'}, {'name': 'Ralf Eberhardt, MD', 'role': 'CONTACT', 'email': 'ralf.eberhardt@thoraxklinik-heidelberg.de', 'phone': '+49 6221-396', 'phoneExt': '8204'}], 'overallOfficials': [{'name': 'Felix JF Herth, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thoraxklinik, Universityof Heidelberg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Felix JF Herth', 'oldOrganization': 'Thoraxklinik, University of Heidelberg'}}}}