Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-28 @ 1:15 AM
Study NCT ID:
NCT04423250
Status:
COMPLETED
Last Update Posted:
2025-02-13
First Post:
2020-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Impact of the Intervention of a Pharmacist in the Operating Room on the Appropriate Use of Sterile Medical DeviceS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-11', 'studyFirstSubmitDate': '2020-06-05', 'studyFirstSubmitQcDate': '2020-06-08', 'lastUpdatePostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'identify compliance with the appropriate use of sterile medical devices', 'timeFrame': '1 day'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Surgery']}, 'descriptionModule': {'briefSummary': 'assess the impact of the intervention of a clinical pharmacist expert in sterile medical devices'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients hospitalized for scheduled surgery in the UDG (Urology Digestive Gynecology) operating room.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\- The patient must be a member or beneficiary of a health insurance plan.\n* The patient is managed for scheduled surgery (full hospitalization or outpatient) in the UDG (Urology Digestive Gynecology) operating room.\n\nExclusion Criteria:\n\n* \\- The subject is in a period of exclusion determined by a previous study.\n* The subject is under judicial protection.\n* The subject (or his/her legal representative) has expressed his/her opposition to participate in the study.\n* The patient is undergoing emergency surgery in the UDG (Urology Digestive Gynecology) operating room.\n* It is not possible to give informed information about the subject.\n\nTranslated with www.DeepL.com/Translator (free version)'}, 'identificationModule': {'nctId': 'NCT04423250', 'acronym': 'OPTIBLOC', 'briefTitle': 'Evaluating the Impact of the Intervention of a Pharmacist in the Operating Room on the Appropriate Use of Sterile Medical DeviceS', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Pilot Study Evaluating the Impact of the Intervention of a Pharmacist in the Operating Room on the Appropriate Use of Sterile Medical Devices and the Economic Repercussions', 'orgStudyIdInfo': {'id': 'NIMAO/2016/JMK-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'impact of the intervention of a clinical pharmacist with expertise in sterile medical devices on non-compliances related to the use of sterile medical devices', 'type': 'OTHER', 'description': '\\- Failure to trace, Lack of product information, absence of product in the operating room'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU de NIMES', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}