Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-03-01 @ 5:54 PM
Study NCT ID:
NCT00613860
Status:
WITHDRAWN
Last Update Posted:
2022-09-02
First Post:
2008-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sequential Endoscopic Lung Volume Reduction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004646', 'term': 'Emphysema'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'complicated patient enrollment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-30', 'studyFirstSubmitDate': '2008-01-31', 'studyFirstSubmitQcDate': '2008-02-12', 'lastUpdatePostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FEV 1 6 Minute walk test', 'timeFrame': '6 months after intervention'}], 'secondaryOutcomes': [{'measure': 'Safety Symptom scores', 'timeFrame': '6 months after intervention'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Endoscopic lung volume reduction, heterogeneous emphysema, interventional bronchoscopy'], 'conditions': ['Emphysema', 'COPD']}, 'referencesModule': {'references': [{'pmid': '17711594', 'type': 'BACKGROUND', 'citation': 'Strange C, Herth FJ, Kovitz KL, McLennan G, Ernst A, Goldin J, Noppen M, Criner GJ, Sciurba FC; VENT Study Group. Design of the Endobronchial Valve for Emphysema Palliation Trial (VENT): a non-surgical method of lung volume reduction. BMC Pulm Med. 2007 Jul 3;7:10. doi: 10.1186/1471-2466-7-10.'}, {'pmid': '16840401', 'type': 'BACKGROUND', 'citation': 'de Oliveira HG, Macedo-Neto AV, John AB, Jungblut S, Prolla JC, Menna-Barreto SS, Fortis EA. Transbronchoscopic pulmonary emphysema treatment: 1-month to 24-month endoscopic follow-up. Chest. 2006 Jul;130(1):190-9. doi: 10.1378/chest.130.1.190.'}, {'pmid': '15680805', 'type': 'BACKGROUND', 'citation': 'Venuta F, de Giacomo T, Rendina EA, Ciccone AM, Diso D, Perrone A, Parola D, Anile M, Coloni GF. Bronchoscopic lung-volume reduction with one-way valves in patients with heterogenous emphysema. Ann Thorac Surg. 2005 Feb;79(2):411-6; discussion 416-7. doi: 10.1016/j.athoracsur.2004.07.048.'}, {'pmid': '15173708', 'type': 'BACKGROUND', 'citation': 'Yim AP, Hwong TM, Lee TW, Li WW, Lam S, Yeung TK, Hui DS, Ko FW, Sihoe AD, Thung KH, Arifi AA. Early results of endoscopic lung volume reduction for emphysema. J Thorac Cardiovasc Surg. 2004 Jun;127(6):1564-73. doi: 10.1016/j.jtcvs.2003.10.005.'}, {'pmid': '27451345', 'type': 'RESULT', 'citation': 'Shah PL, Gompelmann D, Valipour A, McNulty WH, Eberhardt R, Grah C, Egan J, Ficker JH, Wagner M, Witt C, Liebers U, Hopkins P, Gesierich W, Phillips M, Stanzel F, Petermann C, Strange C, Snell G, Herth FJF. Thermal vapour ablation to reduce segmental volume in patients with severe emphysema: STEP-UP 12 month results. Lancet Respir Med. 2016 Sep;4(9):e44-e45. doi: 10.1016/S2213-2600(16)30199-0. Epub 2016 Jul 20. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Patients with heterogenous emphysema benefits from endoscopic lung volume reduction. Until now the technique is limited to one lobe. In case of collateral ventilation patients show no improvement. Between upper and middle lobe exists the highest collateral flow. The trial examine the hypothesis, that sequential ELVR help especially those patients, which have no benefit after lobar exclusion.', 'detailedDescription': 'Patients with heterogenous emphysema undergo ELVR, target lobe is the upper lobe right. After 6 weeks the middle lobe will be block too.\n\nFollow-up period 6 months Primary end points: FEV 1, 6-Minute walk test Secondary endpoints. Safety, Symptom scores Number of patients planned 30'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Heterogenous emphysema\n* FEV1 \\< 45%\n* RV \\> 150%\n* TLC \\> 100%\n* TLCO \\< 40%\n\nExclusion Criteria:\n\n* Homogeneous emphysema\n* Pregnancy\n* PCO2 \\> 50 mmHg'}, 'identificationModule': {'nctId': 'NCT00613860', 'briefTitle': 'Sequential Endoscopic Lung Volume Reduction', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': 'Sequential Endoscopic Lung Volume Reduction in Patients With Heterogeneous Lung Emphysema', 'orgStudyIdInfo': {'id': '02/08'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Zephyr endobronchial valve', 'type': 'DEVICE', 'description': 'Endobronchial valve system to redirect the airflow within the bronchial system'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite, University of Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '69190', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Thoraxklinik, University of Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '90340', 'city': 'Nuremberg', 'country': 'Germany', 'facility': 'Medical Center Nürnberg', 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}], 'overallOfficials': [{'name': 'Felix JF Herth, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thoraxklinik University of Heidelberg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Humboldt-Universität zu Berlin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'CEO', 'investigatorFullName': 'Felix JF Herth', 'investigatorAffiliation': 'Heidelberg University'}}}}