Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 6:57 PM
Study NCT ID:
NCT01357460
Status:
TERMINATED
Last Update Posted:
2022-08-30
First Post:
2011-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Lung Volume Reduction in Patients With Advanced Emphysema Due to alpha1 Antitrypsin Deficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019896', 'term': 'alpha 1-Antitrypsin Deficiency'}, {'id': 'D004646', 'term': 'Emphysema'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D013352', 'term': 'Subcutaneous Emphysema'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'whyStopped': 'difficult patient recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2014-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-24', 'studyFirstSubmitDate': '2011-05-16', 'studyFirstSubmitQcDate': '2011-05-19', 'lastUpdatePostDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in pulmonary function (FEV1 (forced expiratory volume in 1 second) and RV/TLC (residual volume/total lung capacity)', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Number of major complications', 'timeFrame': '3 months'}, {'measure': 'Evaluation of IBV migration rate', 'timeFrame': '3 months'}, {'measure': 'Average changes in pulmonary function (FEV1, VC (vital capacity), RV, TLC, RV/TLC)', 'timeFrame': '3 months'}, {'measure': 'Average changes in 6-minute-walk-distance', 'timeFrame': '3 months'}]}, 'conditionsModule': {'keywords': ['Emphysema', 'alpha1 antitrypsin deficiency', 'endoscopic lung volume reduction'], 'conditions': ['Hereditary Emphysema (Alpha 1-antitrypsin Deficiency)']}, 'descriptionModule': {'briefSummary': 'Patients with advanced heterogeneous emphysema due to alpha1 antitrypsin deficiency might benefit from endoscopic implantation of 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 25 patients with advanced heterogeneous emphysema due to alpha1 antitrypsin deficiency. All patients will undergo treatment at one study centre in Heidelberg. Therapy of all patients consists of implantation of intrabronchial valves (IBV, Spiration, Olympus) in the most emphysematous destroyed lobe.'}, '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* alpha1 antitrypsin deficiency (\\< 80 mg/dl), genotype: PiZS, PiZZ, Pi0/0\n* heterogenous emphysema\n\nExclusion Criteria:\n\n* homogenous emphysema\n* significant bronchiectasis\n* severe concomitant diseases\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT01357460', 'briefTitle': 'Endoscopic Lung Volume Reduction in Patients With Advanced Emphysema Due to alpha1 Antitrypsin Deficiency', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': 'Endoscopic Lung Volume Reduction in Patients With Advanced Emphysema Due to alpha1 Antitrypsin Deficiency', 'orgStudyIdInfo': {'id': 'Protocol D2.0 - 31.08.2010'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Implantation of intrabronchial valves (IBV) (Spiration IBV)', 'type': 'DEVICE', 'otherNames': ['Spiration IBV'], 'description': 'In advanced emphysema due to alpha1 antitrypsin deficiency even optimum treatment including drugs, physical training and possibly oxygen therapy is unable to influence exercise dyspnoea and exercise capacity.Implantation of intrabronchial valves in the most destroyed and hyperinflated lung lobe can improve the elastic recoil of the small airways by a reduction in lung volume and thus leading to more ergonomic breathing mechanics and diaphragm function.The one-way mechanism of these valves allows air to escape from the downstream lung segment without any influx of "new" air during inspiration.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69126', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Thoraxklinik', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'overallOfficials': [{'name': 'Daniela Gompelmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heidelberg University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med. Felix Herth', 'investigatorFullName': 'Felix JF Herth', 'investigatorAffiliation': 'Heidelberg University'}}}}