Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-25 @ 2:37 PM
Study NCT ID:
NCT05006950
Status:
TERMINATED
Last Update Posted:
2022-09-19
First Post:
2021-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SPY Fluorescence Imaging Systems and Indocyanine Green to Determine the Percentage of Successful Critical Anatomy Recognition in Laparoscopic Cholecystectomy Surgeries.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002764', 'term': 'Cholecystitis'}], 'ancestors': [{'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'whyStopped': 'Business/strategic reasons and low accrual rate', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-15', 'studyFirstSubmitDate': '2021-08-09', 'studyFirstSubmitQcDate': '2021-08-09', 'lastUpdatePostDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Outcome 3', 'timeFrame': 'Post op follow- up (7-14 days)', 'description': 'To estimate the number of post-operative complications (related to gall bladder surgery'}], 'primaryOutcomes': [{'measure': 'Outcome 1', 'timeFrame': 'Intra-op visit', 'description': 'To determine the percentage of successful critical anatomy recognition using intra-operative SPY fluorescence imaging and ICG in subjects undergoing laparoscopic cholecystectomy'}], 'secondaryOutcomes': [{'measure': 'Outcome 2', 'timeFrame': 'Intra-op visit', 'description': 'To estimate the number of times a surgeon altered the surgical plan due to information identified/revealed by SPY fluorescence imaging'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cholecystitis']}, 'descriptionModule': {'briefSummary': 'This is a prospective single arm, single center study estimating percentage of successful critical anatomy recognition in laparoscopic cholecystectomy surgeries using SPY fluorescence imaging and ICG, with each surgery also providing a white light 360 degree images.\n\nThe primary objective is to determine the percentage of successful critical anatomy recognition using intra-operative SPY fluorescence imaging and ICG: and to describe complications associated with intra-operative decision making in patients undergoing laparoscopic cholecystectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is 18 years of age or older\n* Subject is scheduled to undergo laparoscopic cholecystectomy, elective or emergent\n* Subject provides informed consent and signs an approved informed consent document for the study\n* Subject is willing to comply with the protocol and study visit schedule\n\nExclusion Criteria:\n\n* Subject is pregnant or lactating\n* Subject has a known allergy or history of adverse reaction to ICG, iodine or iodine dyes\n* Subject has known history of cholangitis, pancreatitis, prior bile duct injury, coagulopathy or known pre-existing liver disease\n* Subjects who, in the Investigator's opinion, have any medical condition that may make the subject a poor candidate for the investigation, interferes with the interpretation of study results, or integrity of the study"}, 'identificationModule': {'nctId': 'NCT05006950', 'briefTitle': 'SPY Fluorescence Imaging Systems and Indocyanine Green to Determine the Percentage of Successful Critical Anatomy Recognition in Laparoscopic Cholecystectomy Surgeries.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stryker Endoscopy'}, 'officialTitle': 'SPY Fluorescence Imaging Systems and Indocyanine Green to Determine the Percentage of Successful Critical Anatomy Recognition in Laparoscopic Cholecystectomy Surgeries.', 'orgStudyIdInfo': {'id': 'CRD10283'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Stryker1688 Fluorescence imaging system', 'type': 'DEVICE', 'description': 'The purpose of this study is to use SPY fluorescence imaging systems and indocyanine green (ICG) as a tool to determine the percentage of successful critical anatomy recognition and to describe complications associated with intra-operative decision making in patients undergoing laparoscopic cholecystectomy.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21401', 'city': 'Annapolis', 'state': 'Maryland', 'country': 'United States', 'facility': 'Anne Arundel Medical Center', 'geoPoint': {'lat': 38.97859, 'lon': -76.49184}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stryker Endoscopy', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}