Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-30 @ 4:08 PM
Study NCT ID:
NCT01457833
Status:
COMPLETED
Last Update Posted:
2022-07-07
First Post:
2011-10-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implantation of Endobronchial Valves Versus Intrabronchial Valves in Patients With Severe Heterogeneous Emphysema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-07-07', 'releaseDate': '2022-08-10'}], 'estimatedResultsFirstSubmitDate': '2022-08-10'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011656', 'term': 'Pulmonary Emphysema'}], 'ancestors': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2012-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-04', 'studyFirstSubmitDate': '2011-10-19', 'studyFirstSubmitQcDate': '2011-10-21', 'lastUpdatePostDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in pulmonary function (FEV1 and RV/TLC)', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Number of severe adverse events', 'timeFrame': '6 months'}, {'measure': 'Evaluation of valve migration rate', 'timeFrame': '6 months'}, {'measure': 'Average changes in pulmonary function (FEV1, IVC, RV, TLC, RV/TLC)', 'timeFrame': '6 months'}, {'measure': 'Average changes in 6-minute-walk-distance', 'timeFrame': '6 months'}]}, 'conditionsModule': {'conditions': ['Pulmonary Emphysema']}, 'descriptionModule': {'briefSummary': 'Patients with advanced heterogeneous emphysema experience improvement in clinical outcomes in the same way following either implantation of endobronchial valves or intrabronchial valves.', 'detailedDescription': 'Patient enrollment and data acquisition is to be carried out on a prospective basis. It is planned to enroll a total of 50 patients with advanced heterogeneous emphysema. After decision to undertake endoscopic lung volume reduction by valve implantation patients will be randomised to two treatment arms. 25 patients receive unilateral IBV treatment or unilateral EBV treatment in each case. All patients will undergo treatment at one study centre in Heidelberg.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pulmonary function: FEV1 \\< 45 %, RV \\> 150 %, TLC \\> 100 %\n* heterogeneous emphysema\n\nExclusion Criteria:\n\n* homogeneous emphysema\n* significant bronchiectasis\n* severe concomitant diseases\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT01457833', 'briefTitle': 'Implantation of Endobronchial Valves Versus Intrabronchial Valves in Patients With Severe Heterogeneous Emphysema', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': 'Endoscopic Lung Volume Reduction by Implantation of Endobronchial Valves (EBV) vs. Intrabronchial Valves (IBV) in Patients With Severe Heterogeneous Emphysema', 'orgStudyIdInfo': {'id': 'Protokoll E1.0-23.05.2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Endobronchial valves (EBV)', 'description': 'Complete occlusion of one emphysematous destroyed lobe by implantation of endobronchial valves', 'interventionNames': ['Device: EBV implantation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intrabronchial valves (IBV)', 'description': 'Complete occlusion of one emphysematous destroyed lobe by implantation of intrabronchial valves', 'interventionNames': ['Device: IBV implantation']}], 'interventions': [{'name': 'EBV implantation', 'type': 'DEVICE', 'otherNames': ['(Zephyr EBV)'], 'description': 'In severe cases of COPD even optimum treatment involving bronchodilatation with drugs, physical training and possibly oxygen therapy is unable to influence exercise capacity and the perception of dyspnoea to a sufficient extent. Given the assumption that the elastic recoil of the small airways can be improved by a reduction in lung volume and pulmonary function overall by more ergonomic breathing mechanics and diaphragm function, various endoscopic procedures for lung volume reduction are available. The most advanced technique is the implantation of valves. The one-way mechanism of these valves allows air to be expelled during exspiration without any influx of air during inspiration.', 'armGroupLabels': ['Endobronchial valves (EBV)']}, {'name': 'IBV implantation', 'type': 'DEVICE', 'otherNames': ['(Spiration IBV)'], 'description': 'In severe cases of COPD even optimum treatment involving bronchodilatation with drugs, physical training and possibly oxygen therapy is unable to influence exercise capacity and the perception of dyspnoea to a sufficient extent. Given the assumption that the elastic recoil of the small airways can be improved by a reduction in lung volume and pulmonary function overall by more ergonomic breathing mechanics and diaphragm function, various endoscopic procedures for lung volume reduction are available. The most advanced technique is the implantation of valves. The one-way mechanism of these valves allows air to be expelled during exspiration without any influx of air during inspiration.', 'armGroupLabels': ['Intrabronchial valves (IBV)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69126', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Thoraxklinik Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor MD', 'investigatorFullName': 'Felix JF Herth', 'investigatorAffiliation': 'Heidelberg University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-08-10', 'type': 'RELEASE'}, {'date': '2023-07-07', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Felix JF Herth, Professor MD, Heidelberg University'}}}}