Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-01-03 @ 10:35 AM
Study NCT ID:
NCT04915560
Status:
WITHDRAWN
Last Update Posted:
2023-05-25
First Post:
2021-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of a Physiological Monitoring for Teleassistance to Isolated Workers in Industrial Cleaning
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': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Percentage of valid data obtains from a professional performing an industrial cleaning task wearing a connected T-shirt.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The French committee refused the amendment.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-23', 'studyFirstSubmitDate': '2021-05-25', 'studyFirstSubmitQcDate': '2021-05-31', 'lastUpdatePostDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of T-shirt recording', 'timeFrame': '12 months', 'description': 'Percentage of valid data from connected T-Shirt. The physiological data is fed back to an integrator and values for respiratory rate (FR), heart rate (HR), temperature (T °) and activity index are calculated over a period of 5 minutes. These values are only calculated if 15% of the raw data can be used over each period of 5 minutes.'}], 'secondaryOutcomes': [{'measure': 'Percentage of alarms processed in less than 3 minutes', 'timeFrame': '12 months', 'description': 'Number of alarms processed in less than 3 minutes'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Work-Related Condition']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to test the feasibility of the monitoring of physiological parameters during operations of industrial cleaning', 'detailedDescription': 'A letter about TIGER study is sent to employees eligible to participate. For volunteers, a written consent is signed after complete oral and written explanation of the protocol is signed.\n\nOn the day of the industrial cleaning task, the employee wears the connected t-shirt and performs the cleaning. Data are retrieved on a 5 min interval basis. Physiological parameters above or beyond pre-defined limits are transmitted as potential alarms to an operational teleassistance center. A missing data (Invalid recording) are considered alarms.\n\nThe number and causes of alarms are determined after the end of the cleaning task.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Employee involved in industrial cleaning task of non-ATEX sites (EXplosive ATmosphere)\n* Affiliation to the French National healthcare system\n* French speaking employee\n\nExclusion Criteria:\n\n* Contraindication to the measures or procedures provided for in the study (physical characteristics do not allow measurements to be taken, wounds, etc.)\n* Pregnancy\n* Inability to understand the study goal\n* Employee protected by decision of law'}, 'identificationModule': {'nctId': 'NCT04915560', 'acronym': 'TIGER', 'briefTitle': 'Feasibility of a Physiological Monitoring for Teleassistance to Isolated Workers in Industrial Cleaning', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': "Etude de faisabilité Portant Sur un Dispositif de Monitoring Physiologique et d'Une Chaine de téléassistance Des Travailleurs isolés au Sein d'Une société de Nettoyage Industriel.", 'orgStudyIdInfo': {'id': '2021-A01390-41'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ORTEC Employee', 'description': 'ORTEC professional employees performing an industrial cleaning task.', 'interventionNames': ['Device: Connected T-shirt']}], 'interventions': [{'name': 'Connected T-shirt', 'type': 'DEVICE', 'description': 'Ware of a connected T-shirt', 'armGroupLabels': ['ORTEC Employee']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}], 'overallOfficials': [{'name': 'Samir HENNI, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Angers'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Ortec International', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}