Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2026-03-02 @ 4:26 AM
Study NCT ID:
NCT03239405
Status:
UNKNOWN
Last Update Posted:
2017-08-04
First Post:
2017-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing the Cost Savings Potential of Orogastric Tubes in Laparoscopic Sleeve Gastrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-01', 'studyFirstSubmitDate': '2017-07-27', 'studyFirstSubmitQcDate': '2017-08-01', 'lastUpdatePostDateStruct': {'date': '2017-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Staples Used', 'timeFrame': '4 hours for the end of surgery', 'description': 'Number of staple loads needed to close stomach'}, {'measure': 'Operation time', 'timeFrame': '4 hours for the end of surgery', 'description': 'Total operation time'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['laparoscopic', 'sleeve', 'gastrectomy'], 'conditions': ['Surgical Procedure, Unspecified']}, 'descriptionModule': {'briefSummary': 'Comparing the operation times and staple loads used between the use of multiple tubes and a bougie versus a one-step suction callibrated system in laparoscopic sleeve gastrectomy.', 'detailedDescription': 'In this study we are comparing the cost/savings of using a bougie with a one-step suction callibrated system in laparoscopic sleeve gastrectomy. We will be looking at OR time and staple usage. This study is not affecting the treatment of the patients in any way. The surgeons would be using the devices regardless of the study. We are simply looking at procedure information after the fact.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals already receiving a laparoscopic sleeve gastrectomy', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient and surgeon have both agreed that a sleeve gastrectomy is a procedure that they want performed.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03239405', 'acronym': 'VS1', 'briefTitle': 'Comparing the Cost Savings Potential of Orogastric Tubes in Laparoscopic Sleeve Gastrectomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Labs LLC'}, 'officialTitle': 'Comparing the Cost Savings Potential of Orogastric Tubes in Laparoscopic Sleeve Gastrectomy', 'orgStudyIdInfo': {'id': 'VIS-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SCS', 'description': 'Treated via suction callibrated system', 'interventionNames': ['Device: Suction callibrated system']}, {'label': 'Bougie', 'description': 'Treated with multiple tubes \\& bougie'}], 'interventions': [{'name': 'Suction callibrated system', 'type': 'DEVICE', 'otherNames': ['Visigi 3D'], 'description': 'One-step suction callibrated SG system', 'armGroupLabels': ['SCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14621', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Rochester General', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Results will be published'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Labs LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Rochester General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}