Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2026-03-04 @ 11:48 AM
Study NCT ID:
NCT02573818
Status:
TERMINATED
Last Update Posted:
2017-03-24
First Post:
2015-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sedasys Post Approval Study Users Response to System Alarms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'franchise closed; no safety concerns', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-22', 'studyFirstSubmitDate': '2015-10-06', 'studyFirstSubmitQcDate': '2015-10-09', 'lastUpdatePostDateStruct': {'date': '2017-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of documented responses/actions taken in response to SEDASYS System alarms (oxygen desaturation, apnea, hypotension, and bradycardia alarms)', 'timeFrame': '<24 hours, i.e., for duration of study procedure'}], 'secondaryOutcomes': [{'measure': 'Fraction of users responses/actions to oxygen desaturation, apnea, hypotension, and/or bradycardia alarms deemed sufficient by Endpoint Adjudication Committee (EAC)', 'timeFrame': 'assessment of sufficient alarms will be reviewed by EAC after 100, 400, and 866 subjects completed the study'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['sedation for EGD and colonoscopy procedures'], 'conditions': ['Conscious Sedation']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the users' responses to the SEDASYS® System alarms during esophagogastroduodenoscopy (EGD) or colonoscopy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male and female subjects 18 years or older scheduled for colonoscopy or EGD', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) I and II\n* male and female\n* Scheduled for routine colonoscopy or EGD\n* ≥18 years of age\n* Able to read, speak, and understand English\n\nExclusion Criteria:\n\n* Physical or psychological condition which would impair trial participation, at the discretion of the PI\n* BMI ≥ 35\n* Pregnancy or lactation\n* Known or suspected hypersensitivity to propofol or fentanyl\n* Use of a fentanyl patch\n* Allergies to eggs, egg products soybeans or soy products\n* Diagnosis of sleep apnea\n* Gastroparesis\n* Full stomach at the time of procedure\n* Participation in any other investigational device or drug study within 30 days of enrollment'}, 'identificationModule': {'nctId': 'NCT02573818', 'briefTitle': 'Sedasys Post Approval Study Users Response to System Alarms', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ethicon Endo-Surgery'}, 'officialTitle': 'Open-Label Post Approval Study of the SEDASYS System User Response to System Alarms', 'orgStudyIdInfo': {'id': 'SED-14-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SEDASYS System', 'interventionNames': ['Device: SEDASYS System']}], 'interventions': [{'name': 'SEDASYS System', 'type': 'DEVICE', 'description': 'propofol sedation with the SEDASYS System', 'armGroupLabels': ['SEDASYS System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43617', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'ProMedica Toledo Hospital', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}], 'overallOfficials': [{'name': 'James F Martin, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ethicon Endo-Surgery, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ethicon Endo-Surgery', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}