Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2026-01-01 @ 8:29 AM
Study NCT ID:
NCT01320566
Status:
TERMINATED
Last Update Posted:
2013-11-14
First Post:
2011-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Continuation Study of the AeriSeal® System Administered at 3 to 4 Sites During a Single Treatment Session for Lung Volume Reduction in Patients With Advanced Emphysema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011656', 'term': 'Pulmonary Emphysema'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}, {'id': 'D004646', 'term': 'Emphysema'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-13', 'studyFirstSubmitDate': '2011-03-15', 'studyFirstSubmitQcDate': '2011-03-21', 'lastUpdatePostDateStruct': {'date': '2013-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in Percent Volume of Lung', 'timeFrame': '48 Weeks following treatment', 'description': 'Computed Tomography (CT) evidence of lobar volume reduction at site(s) of AeriSeal Foam Sealant administration at 48 weeks post treatment, assessed quantitatively by digital integration of CT dicom images collected using a standardized image acquisition and reconstruction algorithm.'}], 'secondaryOutcomes': [{'measure': 'Change in the ratio of Residual Volume (RV) to Total Lung Capacity (TLC)', 'timeFrame': '24 and 48 weeks following treatment', 'description': 'Change from baseline at 24 and 48 weeks in RV/TLC'}, {'measure': 'Change in Forced Expiratory Volume in 1 Second (FEV1)', 'timeFrame': '24 and 48 weeks following treatment', 'description': 'Change from baseline at 24 and 48 weeks in FEV1'}, {'measure': 'Change in Forced Vital Capacity (FVC)', 'timeFrame': '24 and 48 weeks following treatment', 'description': 'Change from baseline at 24 and 48 weeks in FVC'}, {'measure': 'Change in distance walked in six minutes', 'timeFrame': '24 and 48 weeks following treatment', 'description': 'Change from baseline at 24 and 48 weeks in 6 Minutes Walk Test (6MWT)'}, {'measure': 'Change in Medical Research Council Dyspnea (MRCD) score', 'timeFrame': '24 and 48 weeks following treatment', 'description': 'Change from baseline at 24 and 48 weeks in MRCD score'}, {'measure': "Change in St. George's Respiratory Questionnaire (SGRQ)domain score", 'timeFrame': '24 and 48 weeks following treatment', 'description': 'Change from baseline at 24 and 48 weeks in SGRQ total domain score'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Polymeric Lung Volume Reduction (PLVR)', 'Bolilogic Lung Volume Reduction (BLVR)', 'AeriSeal', 'treatment', 'device', 'breathing', 'COPD', 'emphysema', 'heterogeneous', 'homogeneous', 'Pathologic Processes', 'Respiratory Tract Diseases', 'Lung Diseases', 'Pulmonary Disease, Chronic Obstructive'], 'conditions': ['Pulmonary Emphysema', 'Chronic Obstructive Pulmonary Disease(COPD)', 'Lung Diseases']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.aerist.com/', 'label': 'Aeris Therapeutics'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the long term safety and efficacy of AeriSeal System treatment administered at up to 4 subsegments during a single treatment session for lung volume reduction in patients with advanced emphysema through 48 weeks after treatment.', 'detailedDescription': 'Emphysema is a progressive, debilitating disease characterized by destruction of lung tissue as a result of inflammation caused by exposure to noxious inhaled agents for extended periods. The most common cause of this condition is cigarette smoking, although genetic, occupational, and environmental causes account for up to 10% of cases. Despite aggressive public health initiatives aimed at discouraging the use of cigarettes, smoking-related lung diseases remain a significant cause of disability and death worldwide. Due to the number of current and new smokers, emphysema is expected to remain a leading cause of morbidity and mortality for years to come.\n\nThe AeriSeal System is a novel device system being developed for the treatment of advanced emphysema. The AeriSeal System is administered bronchoscopically, and designed to provide the physiological benefits of lung volume reduction without the risks and cost of major surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients must have been enrolled in the 03-C10-002PLV Aeris' Investigational Study and completed a minimum of 12 weeks of follow-up following AeriSeal System treatment."}, 'identificationModule': {'nctId': 'NCT01320566', 'briefTitle': 'A Continuation Study of the AeriSeal® System Administered at 3 to 4 Sites During a Single Treatment Session for Lung Volume Reduction in Patients With Advanced Emphysema', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aeris Therapeutics'}, 'officialTitle': 'A Continuation Study of the AeriSeal® System Administered at 3 to 4 Sites During a Single Treatment Session for Lung Volume Reduction in Patients With Advanced Emphysema', 'orgStudyIdInfo': {'id': '03-C10-003PLV'}}, 'armsInterventionsModule': {'interventions': [{'name': 'AeriSeal System', 'type': 'DEVICE', 'description': 'Not applicable. Follow-Up study only.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '84101', 'city': 'Beersheba', 'country': 'Israel', 'facility': 'The Soroka Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'zip': '49100', 'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'The Rabin Medical Center', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aeris Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}