Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-02-24 @ 7:00 PM
Study NCT ID:
NCT02519920
Status:
UNKNOWN
Last Update Posted:
2015-10-20
First Post:
2015-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lower Fluorescein Sodium Dose on Confocal Laser Endoscopy Image Quality and Yellow Discoloration of the Skin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019793', 'term': 'Fluorescein'}], 'ancestors': [{'id': 'D005452', 'term': 'Fluoresceins'}, {'id': 'D013141', 'term': 'Spiro Compounds'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014966', 'term': 'Xanthenes'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 63}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-19', 'studyFirstSubmitDate': '2015-08-03', 'studyFirstSubmitQcDate': '2015-08-10', 'lastUpdatePostDateStruct': {'date': '2015-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Different ratios of high resolution CLE images among four different fluorescein sodium dose groups(0.01ml/kg,0.02ml/kg,0.05ml/kg,0.1ml/kg)', 'timeFrame': 'six months'}], 'secondaryOutcomes': [{'measure': 'Different degrees of skin yellow dye of patients in four different fluorescein sodium dose groups(0.01ml/kg,0.02ml/kg,0.05ml/kg,0.1ml/kg)', 'timeFrame': 'six months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Image Quality', 'Skin Discoloration']}, 'descriptionModule': {'briefSummary': 'This study was to test an appropriate dose of fluorescein sodium which can provide high image quality to ensure endoscopy examination and have no yellow dye in the skin by a randomized blinded controlled trial.', 'detailedDescription': 'Fluorescein sodium is one of the commonly used staining agents in confocal laser endoscopy, a device for in vivo real-time histological observation of the gastrointestinal mucosa. The conventional intravenous dosage of fluorescein sodium is in the range of 5ml to 10ml of 10% fluorescein. Image quality can be guaranteed with this range of fluorescein sodium, but yellow discoloration of the skin seriously influences daily life. This study was to test whether a lower dose of fluorescein sodium, which has minimal discoloration of skin, can provide satisfied image quality by a randomized blinded controlled trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Only those with normal mucosa and minor gastritis from 18 were included.\n* patients with aged 18 years to 80 years\n* patients with normal mucosa and minor gastritis\n* willing to provide informed consent\n\nExclusion Criteria:\n\n* serious coagulopathy dysfunction, severe cardiopulmonary disease, bronchial asthma, liver and kidney dysfunction, allergy to fluorescein, pregnancy women or breast feeding.\n* patients with peptic ulcer, gastric cancer, remnant stomach, acute serious gastritis were also excluded.\n* unwilling to provide informed consent'}, 'identificationModule': {'nctId': 'NCT02519920', 'briefTitle': 'Lower Fluorescein Sodium Dose on Confocal Laser Endoscopy Image Quality and Yellow Discoloration of the Skin', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'officialTitle': 'Lower Fluorescein Sodium Dose on Confocal Laser Endoscopy Image Quality and Yellow Discoloration of the Skin', 'orgStudyIdInfo': {'id': '2015SDU-QILU-G08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group 1', 'description': 'This group patients were given dosages of fluorescein sodium 0.01ml/kg intravenous administration.', 'interventionNames': ['Drug: fluorescein sodium 0.01ml/kg']}, {'type': 'EXPERIMENTAL', 'label': 'group 2', 'description': 'This group patients were given dosages of fluorescein sodium 0.02ml/kg intravenous administration.', 'interventionNames': ['Drug: fluorescein sodium 0.02ml/kg']}, {'type': 'EXPERIMENTAL', 'label': 'group 3', 'description': 'This group patients were given dosages of fluorescein sodium 0.05ml/kg intravenous administration.', 'interventionNames': ['Drug: fluorescein sodium 0.05ml/kg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group 4', 'description': 'This group patients were given dosages of fluorescein sodium 0.1ml/kg intravenous administration.', 'interventionNames': ['Drug: fluorescein sodium 0.1ml/kg']}], 'interventions': [{'name': 'fluorescein sodium 0.01ml/kg', 'type': 'DRUG', 'description': 'fluorescein Sodium Dose of 0.01ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin', 'armGroupLabels': ['group 1']}, {'name': 'fluorescein sodium 0.02ml/kg', 'type': 'DRUG', 'description': 'fluorescein Sodium Dose of 0.02ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin', 'armGroupLabels': ['group 2']}, {'name': 'fluorescein sodium 0.05ml/kg', 'type': 'DRUG', 'description': 'fluorescein Sodium Dose of 0.05ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin', 'armGroupLabels': ['group 3']}, {'name': 'fluorescein sodium 0.1ml/kg', 'type': 'DRUG', 'description': 'fluorescein Sodium Dose of 0.1ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin', 'armGroupLabels': ['group 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanqing Li, MD, PhD', 'role': 'CONTACT', 'email': 'liyanqing@sdu.edu.cn', 'phone': '86-531-82169236', 'phoneExt': '82169508'}], 'facility': 'Department of Gastroenterology, Qilu Hospital, Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Yanqing Li, PhD.MD', 'role': 'CONTACT', 'email': 'qiluliyanqing@gmail.com', 'phone': '18678827666', 'phoneExt': '82169508'}], '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'}}}}