Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:17 PM
Study NCT ID:
NCT01051258
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2010-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AeriSeal System for Lung Volume Reduction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'Italy']}, 'conditionBrowseModule': {'meshes': [{'id': 'D004646', 'term': 'Emphysema'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D011656', 'term': 'Pulmonary Emphysema'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}], 'ancestors': [{'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011013', 'term': 'Pneumonectomy'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013510', 'term': 'Pulmonary Surgical Procedures'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-25', 'studyFirstSubmitDate': '2010-01-14', 'studyFirstSubmitQcDate': '2010-01-15', 'lastUpdatePostDateStruct': {'date': '2013-06-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in respiratory volume/total lung capacity (RV/TLC) ratio', 'timeFrame': '12 Weeks following final treatment'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in RV/TLC ratio', 'timeFrame': '24 and 48 weeks following treatment'}, {'measure': 'Change from baseline in forced expiratory volume in 1 second (FEV1) (post bronchodilator)', 'timeFrame': '12, 24, 48 weeks following treatment'}, {'measure': 'Change from baseline in MRC dyspnea score', 'timeFrame': '12, 24, 48 weeks following treatment'}, {'measure': 'Change from baseline in 6 minute walk test (MWT)', 'timeFrame': '12, 24, 48 weeks following treatment'}, {'measure': 'Change from baseline in disease-specific health related quality of life assessment (SGRQ)', 'timeFrame': '12, 24, 48 weeks following treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Polymeric Lung Volume Reduction (PLVR)', 'Biologic Lung Volume Reduction (BLVR)', 'AeriSeal', 'treatment', 'device', 'breathing', 'COPD', 'emphysema', 'heterogeneous', 'homogeneous', 'Pathologic Processes', 'Respiratory Tract Diseases', 'Lung Diseases', 'Pulmonary Disease, Chronic Obstructive'], 'conditions': ['Emphysema', 'Chronic Obstructive Pulmonary Disease (COPD)', 'Pulmonary Emphysema', 'Lung Diseases']}, 'referencesModule': {'references': [{'pmid': '22374920', 'type': 'DERIVED', 'citation': 'Magnussen H, Kramer MR, Kirsten AM, Marquette C, Valipour A, Stanzel F, Bonnet R, Behr J, Fruchter O, Refaely Y, Eberhardt R, Herth FJ. Effect of fissure integrity on lung volume reduction using a polymer sealant in advanced emphysema. Thorax. 2012 Apr;67(4):302-8. doi: 10.1136/thoraxjnl-2011-201038. Epub 2012 Feb 28.'}], 'seeAlsoLinks': [{'url': 'http://www.aerist.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of AeriSeal treatment in patients with advanced emphysema.', 'detailedDescription': 'The purpose of this study is to evaluate the safety and efficacy of AeriSeal treatment in patients with advanced homogeneous and heterogeneous emphysema.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have a diagnosis of advanced emphysema as defined by FEV1/FVC\\<70% predicted, FEV1 of \\<50% predicted, TLC \\> 100% predicted, and RV \\> 135% predicted.\n* Patients must have persistent symptoms despite medical therapy and either not be candidates for Lung Volume Reduction Surgery (LVRS) or have elected not to undergo LVRS.\n* Patients must be \\> 40 years of age, have symptoms despite medical therapy, and have none of the prespecified co-morbid conditions that could influence study outcomes or their ability to tolerate bronchoscopy.'}, 'identificationModule': {'nctId': 'NCT01051258', 'briefTitle': 'AeriSeal System for Lung Volume Reduction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aeris Therapeutics'}, 'officialTitle': 'A Study of the AeriSeal System for Lung Volume Reduction in Patients With Advanced Emphysema', 'orgStudyIdInfo': {'id': '03-C08-003PLVGP4-5'}, 'secondaryIdInfos': [{'id': '03-C10-001PLV'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'AeriSeal System', 'type': 'DEVICE', 'otherNames': ['lung volume reduction', 'AeriSeal', 'PLVR'], 'description': 'AeriSeal System for Lung Volume Reduction'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'country': 'Austria', 'facility': 'Otto Wagner Spital Wien Interne Lungenabteilung', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Nice', 'country': 'France', 'facility': 'Service de Pneumologie, Hôpital Pasteur, Centre Hospitalier Universitaire de Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Bad Berka', 'country': 'Germany', 'facility': 'Chefarzt Klinik für Pneumologie', 'geoPoint': {'lat': 50.89982, 'lon': 11.28245}}, {'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Thoraxklinik Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'city': 'Hemer', 'country': 'Germany', 'facility': 'Lungenklinik Hemer', 'geoPoint': {'lat': 51.38707, 'lon': 7.77019}}, {'city': 'München', 'country': 'Germany', 'facility': 'Medizinische Klinik und Poliklinik Klinikum Großhadern', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Beersheba', 'country': 'Israel', 'facility': 'Soroka Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Rabin Medical Center, Beilinson Hospital', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aeris Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}