Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-02-23 @ 8:31 PM
Study NCT ID:
NCT02246569
Status:
UNKNOWN
Last Update Posted:
2015-11-20
First Post:
2014-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lung Volume Reduction Via Coils in Patients With COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-11-18', 'studyFirstSubmitDate': '2014-09-11', 'studyFirstSubmitQcDate': '2014-09-19', 'lastUpdatePostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'breathing strength', 'timeFrame': 'Change of breathing strength 3 (respectively 9) months after the bronchoscopy', 'description': 'Maximal Inspiratory Pressure (PImax) Maximal Expiratory Pressure (PEmax) Neuromuscular drive (P0.1) Sniff nasal pressure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic obstructive pulmonary disease (COPD)', 'endoscopic lung volume reduction', 'RePneu®Coils', 'physical capacity', 'quality of life'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'descriptionModule': {'briefSummary': 'For patients with emphysema lung volume reduction (ELVR) could be an expedient approach for the reduction of distension of the lung. ELVR may be performed using RePneu® Coils. After the insertion of the coils distended lung sections shrink so that healthy parts can expand.\n\nIn the present study investigators intend to examine, whether the insertion of the coils improves diaphragm function and force of the breathing muscles. Investigators hypothesize that reduction of lung volume eliminates or reduces flattening of the diaphragm and relieves breathing muscles, respectively respiratory pump, which aims to reduce dyspnea.', 'detailedDescription': 'In line with routine explorations it is necessary to clarify whether a patient is suitable for the endoscopic lung volume reduction. To address this question lung function diagnostics, 6-minutes-walk-test, blood withdrawal, CT of the thorax, lung perfusion scintigraphy and transthoracic echocardiography have to be performed.\n\nAfter confirmation of the suitability for the endoscopic lung volume reduction patients who fulfill all other eligibility criteria will be educated about the aim and performance of the study by an investigator. After reading the patient information patient may submit his informed written consent. After that information on the risks will be given by a treating physician.\n\nFollowing examination will be performed additional due to the study: determination of the strength of breathing muscles, determination of the life quality index via St.-George-questionary and determination of the depression score via SF-8-questionary (short form-8).\n\nAfter that coils will be implanted and a permanent post-operative examination will be performed for 24 hours.\n\nThree, respectively nine month after the implanting follow up exploration will be performed on the study patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with severe COPD (GOLD stage III or IV)', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* bilateral lung emphysema after CT with sufficient amount of tissue to perform RePneu Coil implantation at the discretion of the treating physicians\n* homogeneous or heterogeneous emphysema\n* previous guidelines-based therapy of COPD (including vaccinations against Pneumococcal infections and seasonal influenza)\n* nicotine abstention for not less than three months, documented by CO-HB (haemoglobin) \\< 2%\n* FEV 1 (Forced Expiratory Volume 1 / one second capacity) ≤ 45% of reference value, after bronchodilatation\n* total lung capacity (TLC) ≥ 100% of reference value\n* residual volume (RV) ≥ 175% of reference value\n* patient's suitability for endoscopic lung volume reduction according to multidisciplinary decision of pneumology and thorax surgery division.\n* signed Informed Consent\n* understanding of the nature, significance and implications of the study\n* ability to understand and follow instructions of the study stuff\n\nExclusion Criteria:\n\n* echo-cardiographic right ventricular pressure (PAPsys) \\> 50 mmHg\n* indication for a permanent anticoagulation therapy (besides ASS)\n* pulmonal cachexia\n* pregnancy and lactating\n* permanent treatment with \\> 20 mg Prednison per day\n* hospitalisation due to a COPD-exacerbation in the last 3 months\n* \\> 3 steroid-treated exacerbations in the last year\n* Increase of FEV1 (Forced Expiratory Volume) ≥ 20% after bronchodilatation\n* severe diffusion impairment (DLCO \\< 20%)"}, 'identificationModule': {'nctId': 'NCT02246569', 'briefTitle': 'Lung Volume Reduction Via Coils in Patients With COPD', 'organization': {'class': 'OTHER', 'fullName': 'RWTH Aachen University'}, 'officialTitle': 'Impact of Endoscopic Lung Volume Reduction Via Coils on Inspiratory Muscle Strength in Patients With COPD', 'orgStudyIdInfo': {'id': '14-001'}}, 'contactsLocationsModule': {'locations': [{'zip': '52074', 'city': 'Aachen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Michael Dreher, Univ.-Prof.', 'role': 'CONTACT', 'email': 'mdreher@ukaachen.de', 'phone': '+492418088763'}, {'name': 'Tobias Müller, PD Dr.med.', 'role': 'CONTACT', 'email': 'tobmueller@ukaachen.de', 'phone': '+492418088763'}], 'facility': 'RWTH Univerity Hospital MK1', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}], 'centralContacts': [{'name': 'Michael Dreher, Univ.-Prof.', 'role': 'CONTACT', 'email': 'mdreher@ukaachen.de', 'phone': '+49241 80 88763'}, {'name': 'Tobias Müller, PD Dr.med.', 'role': 'CONTACT', 'email': 'tobmueller@ukaachen.de', 'phone': '+49241 80 88763'}], 'overallOfficials': [{'name': 'Michael Dreher, Univ.-Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RWTH University Hospital MK1'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RWTH Aachen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}