Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-26 @ 11:35 PM
Study NCT ID:
NCT00684892
Status:
COMPLETED
Last Update Posted:
2009-01-22
First Post:
2008-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Feasibility Study of the Chartis System With Heterogeneous Emphysema Prior to Endobronchial Lung Volume Reduction (ELVR)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004646', 'term': 'Emphysema'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-20', 'studyFirstSubmitDate': '2008-05-23', 'studyFirstSubmitQcDate': '2008-05-27', 'lastUpdatePostDateStruct': {'date': '2009-01-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'Until end of study procedure'}], 'secondaryOutcomes': [{'measure': 'Technical success', 'timeFrame': 'During procedure and up 1 week post procedure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Emphysema', 'Endobronchial Lung Volume Reduction'], 'conditions': ['Heterogeneous Emphysema']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and feasibility of the Chartis System in measuring air flow and pressures in isolated lung compartments in emphysema patients prior to endobronchial lung volume reduction (ELVR).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Heterogeneous emphysema as determined by high-resolution CT scan\n* Scheduled for clinically indicated ELVR procedure\n\nExclusion Criteria:\n\n* Hyperexcretive chronic bronchitis or excessive sputum secretion\n* Active pulmonary infection\n* Active asthma or lung hyper-responsiveness'}, 'identificationModule': {'nctId': 'NCT00684892', 'briefTitle': 'Safety and Feasibility Study of the Chartis System With Heterogeneous Emphysema Prior to Endobronchial Lung Volume Reduction (ELVR)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pulmonx Corporation'}, 'officialTitle': 'A Safety and Feasibility Study of the Chartis System in Subjects With Heterogeneous Emphysema Prior to Endobronchial Lung Volume Reduction (ELVR)', 'orgStudyIdInfo': {'id': 'PRT01029'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Device: Chartis System']}], 'interventions': [{'name': 'Chartis System', 'type': 'DEVICE', 'description': 'Assessment of airway flow and pressure', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-69126', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Thoraxklinik am Universitatsklinikum Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'overallOfficials': [{'name': 'Felix Herth, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thoraxklinik am Universitatsklinikum Heidelberg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pulmonx Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Carol Anne Yarbrough, RN, Director, Clinical Affairs', 'oldOrganization': 'Pulmonx, Inc.'}}}}