Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT02070627
Status:
COMPLETED
Last Update Posted:
2014-11-03
First Post:
2014-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy -- Use in Acute Cholecystitis Sub-Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D041881', 'term': 'Cholecystitis, Acute'}], 'ancestors': [{'id': 'D002764', 'term': 'Cholecystitis'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007208', 'term': 'Indocyanine Green'}], 'ancestors': [{'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-30', 'studyFirstSubmitDate': '2014-02-21', 'studyFirstSubmitQcDate': '2014-02-24', 'lastUpdatePostDateStruct': {'date': '2014-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events related to use of indocyanine green (ICG)', 'timeFrame': 'Injection to 2 wk follow-up', 'description': 'Adverse events related to the use of ICG from the time of injection through the initial post-operative clinic visit will be recorded and assessed.'}, {'measure': 'Anatomic identification with NIRF-C and IOC', 'timeFrame': 'Intraoperative', 'description': 'Anatomic identification with near-infrared fluorescence cholangiography and standard of care intraoperative cholangiography (IOC) will be used to calculate a 95% confidence interval for the effectiveness of this modality.'}, {'measure': 'Procedure time', 'timeFrame': 'Intraoperative', 'description': 'The time it takes to perform near infrared fluorescence cholangiography and standard of care intraoperative cholangiography will be compared.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['acute cholecystitis', 'acute cholangitis', 'cholecystectomy'], 'conditions': ['Acute Cholecystitis', 'Acute Cholangitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate an imaging system using Indocyanine Green (ICG) to assist in real-time identification of anatomy during cholecystectomy (gallbladder removal) in patients with acute cholecystitis and cholangitis. We propose to define the effectiveness of NIRF-C in identifying the cystic duct junction during cholecystectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-89\n* Planned laparoscopic cholecystectomy\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Pregnant\n* Allergy to ICG, iodine, and/or shellfish\n* Lactating'}, 'identificationModule': {'nctId': 'NCT02070627', 'acronym': 'NIRF-C Acute', 'briefTitle': 'Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy -- Use in Acute Cholecystitis Sub-Study', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy Sub-Study', 'orgStudyIdInfo': {'id': '2011H0239S'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NIRF-C and IOC', 'description': 'Each enrolled subject will undergo injection with indocyanine green (ICG), intraoperative near infrared fluorescence cholangiography (NIRF-C) and standard of care intraoperative cholangiography.', 'interventionNames': ['Drug: Indocyanine Green (ICG)', 'Device: Near Infrared Fluorescence Cholangiography (NIRF-C)']}], 'interventions': [{'name': 'Indocyanine Green (ICG)', 'type': 'DRUG', 'description': '60-30 minutes prior to cholecystectomy, 2.5 mg of indocyanine green (ICG) will be injected intravenously. An additional 2.5 mg of ICG may be injected intraoperatively if the fluorescence fades prior to imaging.', 'armGroupLabels': ['NIRF-C and IOC']}, {'name': 'Near Infrared Fluorescence Cholangiography (NIRF-C)', 'type': 'DEVICE', 'otherNames': ['Stryker 1488 Camera System', 'Stryker L9000 Light Source', 'Stryker 1488 Coupler', 'Stryker 10mm Ideal Eyes Laparoscope (0 and 30 degree)'], 'description': 'Near infrared fluorescence cholangiography will be performed intraoperatively in order to image anatomy.', 'armGroupLabels': ['NIRF-C and IOC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Vimal K Narula, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stryker Instruments', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Narula, Vimal K, MD', 'investigatorAffiliation': 'Ohio State University'}}}}