Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-01-04 @ 12:09 AM
Study NCT ID:
NCT00677794
Status:
COMPLETED
Last Update Posted:
2015-09-25
First Post:
2008-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Small Bowel Cleansing Prior to Video Capsule Endoscopy Examination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011092', 'term': 'Polyethylene Glycols'}], 'ancestors': [{'id': 'D005026', 'term': 'Ethylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 198}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-23', 'studyFirstSubmitDate': '2008-05-13', 'studyFirstSubmitQcDate': '2008-05-14', 'lastUpdatePostDateStruct': {'date': '2015-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'small bowel cleansing', 'timeFrame': 'during exam'}], 'secondaryOutcomes': [{'measure': 'yield of Video Capsule Endoscopy (VCE) in iron deficiency', 'timeFrame': 'during study'}, {'measure': 'tolerance of preparation', 'timeFrame': 'during preparation'}, {'measure': 'effect of preparation on blood chemistry', 'timeFrame': '24 hours after ingestion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Video Capsule Endoscopy', 'Small Bowel'], 'conditions': ['Endoscopy']}, 'referencesModule': {'references': [{'pmid': '27451294', 'type': 'DERIVED', 'citation': 'Hookey L, Louw J, Wiepjes M, Rubinger N, Van Weyenberg S, Day AG, Paterson W. Lack of benefit of active preparation compared with a clear fluid-only diet in small-bowel visualization for video capsule endoscopy: results of a randomized, blinded, controlled trial. Gastrointest Endosc. 2017 Jan;85(1):187-193. doi: 10.1016/j.gie.2016.07.028. Epub 2016 Jul 21.'}]}, 'descriptionModule': {'briefSummary': 'There remains debate regarding whether small bowel cleansing is required prior to video capsule endoscopy, and if so, which method is best. This study prospectively tests cleansing with no preparation, preparation with picosalax, and preparation with polyethylene glycol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing VCE.\n\nExclusion Criteria:\n\n* bowel obstruction or ileus;\n* known stricture or fistula;\n* previous small bowel surgery;\n* severe gastroparesis or motility disorder\n* renal impairment (serum creatinine over normal range within three months of study);\n* congestive heart failure;\n* cirrhosis;\n* implanted cardiac pacemaker or defibrillator or other electromedical device;\n* pregnancy.'}, 'identificationModule': {'nctId': 'NCT00677794', 'briefTitle': 'Small Bowel Cleansing Prior to Video Capsule Endoscopy Examination', 'organization': {'class': 'OTHER', 'fullName': "Queen's University"}, 'officialTitle': 'Small Bowel Cleansing Prior to Video Capsule Endoscopy Examination: a Randomized, Blinded, Controlled Trial', 'orgStudyIdInfo': {'id': 'small bowel cleansing and VCE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Clear fluids only after lunch.', 'interventionNames': ['Drug: Clear fluids']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Two sachets of picosalax the evening prior to Video Capsule Endoscopy (VCE).', 'interventionNames': ['Drug: Picosalax']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Polyethylene glycol, 2 liters the evening prior to Video Capsule Endoscopy (VCE).', 'interventionNames': ['Drug: Polyethylene glycol']}], 'interventions': [{'name': 'Clear fluids', 'type': 'DRUG', 'description': 'Clear fluids only after lunch.', 'armGroupLabels': ['1']}, {'name': 'Picosalax', 'type': 'DRUG', 'description': 'Two sachets the evening prior to Video Capsule Endoscopy (VCE).', 'armGroupLabels': ['2']}, {'name': 'Polyethylene glycol', 'type': 'DRUG', 'description': 'Two (2) litres the evening prior to Video Capsule Endoscopy (VCE).', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hotel Dieu Hospital', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}], 'overallOfficials': [{'name': 'Lawrence Hookey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Queen's University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Queen's University", 'class': 'OTHER'}, 'collaborators': [{'name': 'American Society for Gastrointestinal Endoscopy', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Dr. Lawrence Hookey', 'investigatorAffiliation': "Queen's University"}}}}