Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-03-09 @ 10:57 PM
Study NCT ID:
NCT02776020
Status:
UNKNOWN
Last Update Posted:
2016-05-18
First Post:
2016-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-invasive, Real-time Anesthetic Drug-monitoring System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-15', 'studyFirstSubmitDate': '2016-05-09', 'studyFirstSubmitQcDate': '2016-05-15', 'lastUpdatePostDateStruct': {'date': '2016-05-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Propofol Blood Levels', 'timeFrame': 'Half hour', 'description': 'Graphic display on monitor of real-time changes'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine efficacy of the "CorrecDose" device to continuously and non-invasively follow the changes in propofol concentrations in the participants\' blood.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women undergoing propofol sedation while undergoing trans vaginal ovum retrieval (TVOR) for in vitro fertilization (IVF).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women who have signed Informed consent form\n* Women undergoing Trans vaginal ovum retrieval (TVOR) for invitro fertilization (IVF) and will be sedated with propofol administered intravenos (IV)\n\nExclusion Criteria:\n\n* Women with background diseases\n* Women with chronic use of drug and medication\n* Women with peripheral blood vessels problems\n* Women with high blood pressure\n* Women with body mass index (BMI) score over 35 or less than 18'}, 'identificationModule': {'nctId': 'NCT02776020', 'acronym': 'ADM', 'briefTitle': 'Non-invasive, Real-time Anesthetic Drug-monitoring System', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'orgStudyIdInfo': {'id': '0347-15 RBM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Propofol sedated patients', 'description': 'Women undergoing a short trans vaginal ovum retrieval (TVOR) will be sedated with propofol , and monitored non-invasively for changes in blood propofol concentration levels. Propofol dosages will be adapted according to patients vital signs and their reaction to noxious stimuli exerted during the trans vaginal ovum retrieval (TVOR) procedure, irrespective to the proposed study in which these participants undergo.Those changes of administered propofol dosages will be observed by the anesthetic drug monitor (ADM). Propfol is administered by the anesthesiologist in a routine manner and according to anesthesiologist discretion .', 'interventionNames': ['Device: CorrecDose Infrared Monitor']}], 'interventions': [{'name': 'CorrecDose Infrared Monitor', 'type': 'DEVICE', 'description': "The monitor is attached to patient's wrist and ear in order to measure changes in propofol concentrations in blood", 'armGroupLabels': ['Propofol sedated patients']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Philippe Abecassis, MD', 'role': 'CONTACT', 'email': 'p_abecassis@rambam.health.gov.il', 'phone': '+972502061058'}], 'overallOfficials': [{'name': 'Philippe Abecassis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of women and obstetrics anesthesiology unit', 'investigatorFullName': 'ABECASSIS PHILIPPE', 'investigatorAffiliation': 'Rambam Health Care Campus'}}}}