Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 11:21 PM
Study NCT ID:
NCT00689234
Status:
UNKNOWN
Last Update Posted:
2013-08-07
First Post:
2008-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diaphragm Plication in Adults With Phrenic Nerve Paralysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2014-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-08-05', 'studyFirstSubmitDate': '2008-05-30', 'studyFirstSubmitQcDate': '2008-06-02', 'lastUpdatePostDateStruct': {'date': '2013-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dyspnea', 'timeFrame': '6 months after inclusion', 'description': 'Functional outcome measured by dyspnea score'}, {'measure': 'Dyspnea', 'timeFrame': '12 months after inclusion', 'description': 'Functional outcome measured by dyspnea score'}, {'measure': 'Exercise capacity', 'timeFrame': '6 months after inclusion', 'description': 'Functional outcome measured by exercise testing'}, {'measure': 'Exercise capacity', 'timeFrame': '12 months after inclusion', 'description': 'Functional outcome measured by exercise testing'}], 'secondaryOutcomes': [{'measure': 'Pulmonary function', 'timeFrame': '6 months after inclusion', 'description': 'Measurement of pulmonary function'}, {'measure': 'Pulmonary function', 'timeFrame': '12 months after inclusion', 'description': 'Measurement of pulmonary function'}, {'measure': 'Sleep', 'timeFrame': '6 months after inclusion', 'description': 'Polysomnography evaluation'}, {'measure': 'Sleep', 'timeFrame': '12 months after inclusion', 'description': 'Polysomnography evaluation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Phrenic Nerve Paralysis']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate the impact of unilateral or bilateral diaphragm plication in a prospective randomised controlled way on symptoms, pulmonary function including gas exchange, respiratory muscle strength, exercise capacity and breathing during sleep in patients with proven uni- or bilateral phrenic nerve paralysis present for at least 1 year without any evidence of spontaneous recovery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Uni- or bilateral diaphragmatic paralysis due to phrenic nerve paralysis present for at least 1 year\n* With reduced VC, at least in supine position and no significant change in VC for at least 6 months\n* At the time of randomisation symptomatic patient, defined by one of the following symptoms: not able to sleep in supine position or exertional dyspnoea\n\nExclusion Criteria:\n\n* No informed consent obtained\n* Other disease that may interfere with the evaluation of pulmonary function or the exercise capacity: COPD, parenchymal lung disease on the thoracic X-ray, documented ischemic heart disease or left heart failure, active rheumatological disease, severe orthopaedic problems,....\n* Abnormal neuromuscular clinical investigation (apart from diaphragmatic dysfunction) and/or abnormal electromyography of the limbs compatible with generalized neuromuscular disease\n* Known diseases resulting in abnormal blood coagulation\n* Proven oncological origine of the phrenic nerve paralysis\n* Age below 18 yrs old'}, 'identificationModule': {'nctId': 'NCT00689234', 'briefTitle': 'Diaphragm Plication in Adults With Phrenic Nerve Paralysis', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'officialTitle': 'Diaphragm Plication in Adults With Phrenic Nerve Paralysis: a Randomised Controlled Study', 'orgStudyIdInfo': {'id': 'B32220083458 (no sponsor)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'A', 'description': 'At time of inclusion randomised in the "no intervention" arm (the subjects will be re-evaluated 6 months later and will get intervention at that time (cross-over protocol)', 'interventionNames': ['Procedure: diaphragm plication 6 months after inclusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'At time of inclusion the subject get the intervention', 'interventionNames': ['Procedure: diaphragm plication at time of inclusion']}], 'interventions': [{'name': 'diaphragm plication 6 months after inclusion', 'type': 'PROCEDURE', 'description': 'thoracotomy', 'armGroupLabels': ['A']}, {'name': 'diaphragm plication at time of inclusion', 'type': 'PROCEDURE', 'description': 'thoracotomy', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Bertien MA Buyse, MD,Phd', 'role': 'CONTACT', 'email': 'Bertien.Buyse@uz.kuleuven.ac.be', 'phone': '32 16 34 68 00'}, {'name': 'Buyse MA Buyse, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Gasthuisberg Divisionof Pulmonology', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'centralContacts': [{'name': 'Bertien MA Buyse, MD,PhD', 'role': 'CONTACT', 'email': 'Bertien.Buyse@uz.kuleuven.ac.be', 'phone': '32 16 34 68 00'}, {'name': 'Marc Decramer, MD,PhD', 'role': 'CONTACT', 'email': 'Marc.Decramer@uz.kuleuven.ac.be', 'phone': '32 16 34 68 00'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Marc Decramer', 'investigatorAffiliation': 'KU Leuven'}}}}