Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-02-25 @ 8:50 PM
Study NCT ID:
NCT03655860
Status:
WITHDRAWN
Last Update Posted:
2023-11-28
First Post:
2018-08-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of SIMEOX on Flow and Volume
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Never started, was replaced by NCT04150601', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-22', 'studyFirstSubmitDate': '2018-08-28', 'studyFirstSubmitQcDate': '2018-08-30', 'lastUpdatePostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in expiratory volume', 'timeFrame': '5min', 'description': 'Expiratory volume before and during the use of the SIMEOX will be compared'}, {'measure': 'Change in expiratory volume flow rate', 'timeFrame': '5min', 'description': 'Expiratory flow rate before and during the use of the SIMEOX will be compared'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study will investigate the effects of the SIMEOX (an airway clearance device) on flow and volume generated in healthy subjects', 'detailedDescription': 'This is a pilot study assessing the effect of the SIMEOX device on flow and volume generated in healthy subjects.\n\nAssessment of flow and volume will be performed before and during the application of the SIMEOX. Vital capacity and expiratory flow will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to understand the instructions\n\nExclusion Criteria:\n\n* Obesity (BMI \\> 30kg/m²)\n* Active smoker\n* Severe scoliosis\n* Cardiovascular ou neuromuscular disease'}, 'identificationModule': {'nctId': 'NCT03655860', 'briefTitle': 'Effects of SIMEOX on Flow and Volume', 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'officialTitle': 'Evaluation of SIMEOX on Flow and Volume Elicited in Healthy Subjects', 'orgStudyIdInfo': {'id': 'SIMEOX-01'}, 'secondaryIdInfos': [{'id': '2018/08AOU/312', 'type': 'OTHER', 'domain': 'CEHF'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SIMEOX', 'description': 'Use of the device SIMEOX to exhale', 'interventionNames': ['Device: SIMEOX']}], 'interventions': [{'name': 'SIMEOX', 'type': 'DEVICE', 'description': 'SIMEOX is a device generating a succession of gentle depression at the mouth.', 'armGroupLabels': ['SIMEOX']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'William Poncin', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Grégory Reychler, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}