Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-26 @ 1:35 AM
Study NCT ID:
NCT06254833
Status:
RECRUITING
Last Update Posted:
2024-02-12
First Post:
2024-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Microdosing ICG for Serial Colonic Perfusion Study During Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-03', 'studyFirstSubmitDate': '2024-01-11', 'studyFirstSubmitQcDate': '2024-02-03', 'lastUpdatePostDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ability to assess perfusion', 'timeFrame': 'up to 30 days post operatively', 'description': 'likert scale evaluation survey performed by surgeon'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Perfusion; Complications']}, 'descriptionModule': {'briefSummary': 'using microdosing of ICG vs regular dosing of ICG for perfusion assessment during surgery', 'detailedDescription': 'Randomized dosing of 7.5mg or 0.75mg of ICG injection during surgery for bowel perfusion assessment using new imaging equipment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patient undergoing intestinal resection surgery\n\nExclusion Criteria:\n\n* pregnancy, renal insufficiency'}, 'identificationModule': {'nctId': 'NCT06254833', 'briefTitle': 'Microdosing ICG for Serial Colonic Perfusion Study During Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Microdosing ICG for Serial Colonic Perfusion Study During Surgery', 'orgStudyIdInfo': {'id': '311249-00001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'regular dose ICG'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'micro dose icg', 'interventionNames': ['Other: micro dosing of ICG']}], 'interventions': [{'name': 'micro dosing of ICG', 'type': 'OTHER', 'otherNames': ['small dose of injection if icg'], 'description': 'smaller dose of injection of ICG. All devices used are FDA approved in clinical use.', 'armGroupLabels': ['micro dose icg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shanglei Liu', 'role': 'CONTACT'}], 'facility': 'UC San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'centralContacts': [{'name': 'Shanglei Liu', 'role': 'CONTACT', 'email': 'jtt005@health.ucsd.edu', 'phone': '(858)249-1837'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanglei Liu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Shanglei Liu', 'investigatorAffiliation': 'University of California, San Diego'}}}}