Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2026-01-04 @ 5:43 PM
Study NCT ID:
NCT03620695
Status:
UNKNOWN
Last Update Posted:
2018-08-08
First Post:
2018-07-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Confocal Laser Endomicroscopy With Topical Cresyl Violet for Colorectal Polyps
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-06', 'studyFirstSubmitDate': '2018-07-31', 'studyFirstSubmitQcDate': '2018-08-06', 'lastUpdatePostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The pCLE with topical CV interpretation criteria for the characterization of colorectal polyps with histopathological correlation', 'timeFrame': '5 months'}, {'measure': 'Number of diagnostic agreement between pCLE with topical CV and histopathological results', 'timeFrame': '5 months'}, {'measure': 'Number of participants with procedure-related adverse events', 'timeFrame': '5 months'}, {'measure': 'Number of pCLE imaging failure with topical CV', 'timeFrame': '5 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Polyps']}, 'descriptionModule': {'briefSummary': 'Probe-based confocal laser endomicroscopy (pCLE) has been shown to a reliable diagnostic method enabling in vivo microscopic imaging during ongoing endoscopy. Usually fluorescein then serves as a contrast agent for pCLE, but it does not allow direct nuclear visualization, must be injected, leads to a transient skin discoloration, and may have allergic side effects. This study aimed to establish a single topical dye, cresyl violet (CV) for pCLE imaging, to describe pCLE interpretation criteria for the characterization of colorectal polyps with histopathological correlation, and to perform the validation of these criteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients undergoing surveillance or screening colonoscopies will be recruited in this study at Qilu Hospital, Shandong University.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged from 18 to 75 years, with polyps found during surveillance or screening colonoscopies.\n\nExclusion Criteria:\n\n* Contraindications to CV (such as allergy);\n* Pregnancy or breastfeeding;\n* Serous cardiopulmonary diseases, severe coagulopathy dysfunction, impaired kidney function;\n* Inability to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT03620695', 'briefTitle': 'Confocal Laser Endomicroscopy With Topical Cresyl Violet for Colorectal Polyps', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'officialTitle': 'Probe-based Confocal Laser Endomicroscopy With Topical Cresyl Violet for Diagnosis of Colorectal Polyps', 'orgStudyIdInfo': {'id': '2018SDU-QILU-03'}}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanqing Li, PhD. MD.', 'role': 'CONTACT', 'email': 'liyanqing@sdu.edu.cn', 'phone': '18678827666'}], 'facility': 'Department of Gastroenterology, Qilu Hospital, Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Yanqing Li, PhD. MD.', 'role': 'CONTACT', 'email': 'liyanqing@sdu.edu.cn', 'phone': '18678827666'}], 'overallOfficials': [{'name': 'Yanqing Li, PhD. MD.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Gastroenterology, Qilu Hospital, Shandong University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice president of Qilu Hospital', 'investigatorFullName': 'Yanqing Li', 'investigatorAffiliation': 'Shandong University'}}}}