Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-01-01 @ 4:15 PM
Study NCT ID:
NCT00817167
Status:
COMPLETED
Last Update Posted:
2014-11-19
First Post:
2009-01-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Added Value of inReach Software on Performance Characteristics of Standard Bronchoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-17', 'studyFirstSubmitDate': '2009-01-01', 'studyFirstSubmitQcDate': '2009-01-05', 'lastUpdatePostDateStruct': {'date': '2014-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bronchoscopy Diagnostic Yield, compared between two study groups and calculated as percentage of true diagnoses from total number of bronchoscopy procedures.', 'timeFrame': 'Until the definitive diagnosis is obtained'}], 'secondaryOutcomes': [{'measure': 'Bronchoscopy Safety Profile, compared between two groups and calculated as percentage of bronchoscopy-related adverse events.', 'timeFrame': 'At discharge from bronchoscopy unit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Known or suspected lung disease', 'Candidates for non-emergency bronchoscopy'], 'conditions': ['Lung Disease']}, 'referencesModule': {'references': [{'pmid': '16608948', 'type': 'BACKGROUND', 'citation': 'Schwarz Y, Greif J, Becker HD, Ernst A, Mehta A. Real-time electromagnetic navigation bronchoscopy to peripheral lung lesions using overlaid CT images: the first human study. Chest. 2006 Apr;129(4):988-94. doi: 10.1378/chest.129.4.988.'}, {'pmid': '16873767', 'type': 'BACKGROUND', 'citation': 'Gildea TR, Mazzone PJ, Karnak D, Meziane M, Mehta AC. Electromagnetic navigation diagnostic bronchoscopy: a prospective study. Am J Respir Crit Care Med. 2006 Nov 1;174(9):982-9. doi: 10.1164/rccm.200603-344OC. Epub 2006 Jul 27.'}, {'pmid': '17400670', 'type': 'BACKGROUND', 'citation': 'Eberhardt R, Anantham D, Herth F, Feller-Kopman D, Ernst A. Electromagnetic navigation diagnostic bronchoscopy in peripheral lung lesions. Chest. 2007 Jun;131(6):1800-5. doi: 10.1378/chest.06-3016. Epub 2007 Mar 30.'}], 'seeAlsoLinks': [{'url': 'http://www.superdimension.com', 'label': 'superDimension Inc.'}]}, 'descriptionModule': {'briefSummary': 'The study is aimed to evaluate and describe the added value of inReach planning software on performance characteristics of standard bronchoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Candidates for non-emergency bronchoscopy\n* Must provide signed informed consent\n* Male or female above 18 years old\n* Lung lesions up to 3 cm in size (in largest diameter), non-visible by standard bronchoscope\n\nExclusion Criteria:\n\n* CT done over a month before the bronchoscopy procedure'}, 'identificationModule': {'nctId': 'NCT00817167', 'briefTitle': 'Added Value of inReach Software on Performance Characteristics of Standard Bronchoscopy', 'organization': {'class': 'INDUSTRY', 'fullName': 'superDimension Ltd.'}, 'officialTitle': 'Open Label, Randomized, Comparative, Single Center, Pilot Study to Assess the Added Value of inReach Technology Software on Performance Characteristics of Standard Bronchoscopy.', 'orgStudyIdInfo': {'id': 'DPR0006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'inReach (A)', 'description': 'Bronchoscopy procedure is planned using inReach planning software', 'interventionNames': ['Device: inReach bronchoscopy planning software']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control (B)', 'description': 'Bronchoscopy procedure is planned using standard CT viewer software', 'interventionNames': ['Device: Standard lung CT viewer']}], 'interventions': [{'name': 'inReach bronchoscopy planning software', 'type': 'DEVICE', 'description': 'inReach planning software creates three-dimensional lung CT reconstruction, enabling rapid virtual endoscopic depiction of the airways that allows to plan bronchoscopy virtually.', 'armGroupLabels': ['inReach (A)']}, {'name': 'Standard lung CT viewer', 'type': 'DEVICE', 'description': 'CT viewer, used for standard bronchoscopy', 'armGroupLabels': ['Control (B)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Pulmonology Department, Tel Aviv Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'overallOfficials': [{'name': 'Avi Mann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pulmonology Department, Tel Aviv Sourasky Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'superDimension Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}