Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-03-14 @ 4:58 PM
Study NCT ID:
NCT06266104
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Image Enhanced Endoscopy IBD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 270}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-10', 'studyFirstSubmitDate': '2024-02-04', 'studyFirstSubmitQcDate': '2024-02-10', 'lastUpdatePostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dysplasia Detection Rate', 'timeFrame': '2 years', 'description': 'Overall Dysplasia Detection rate'}], 'secondaryOutcomes': [{'measure': 'Withdrawal times', 'timeFrame': '2 years', 'description': 'Withdrawal time for procedure'}, {'measure': 'Characterisation of lesions', 'timeFrame': '2 years', 'description': 'Accurate characterisation compared to histology'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Bowel Diseases', 'Dysplasia']}, 'descriptionModule': {'briefSummary': 'Dye- spray chromoendoscopy remains the recommended gold standard approach for IBD dysplasia surveillance colonoscopy however recently published European and American guidelines recommend either dye-spray or virtual chromoendoscopy can be used for surveillance. The newer Imaged Enhanced Endoscopy technologies TXI and LCI have not formally been evaluated in IBD surveillance in a randomised controlled trial setting. These modes can easily be applied during colonoscopy and if demonstrated to be effective may save time and eliminate the need for dye-spray chromoendoscopy in the future.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with inflammatory bowel disease aged 18 to 75 years, that meet Australian recommendations to undergo surveillance colonoscopy will be identified and invited participate in the study.\n\nExclusion Criteria:\n\n* Any active disease\n* Inadequate bowel preparation\n* Previous surgical resection involving the colon\n* History of bowel cancer'}, 'identificationModule': {'nctId': 'NCT06266104', 'briefTitle': 'Image Enhanced Endoscopy IBD', 'organization': {'class': 'OTHER', 'fullName': 'Royal Perth Hospital'}, 'officialTitle': 'Image Enhanced Endoscopy Technology to Improve the Detection of Colorectal Dysplasia in Patients With Inflammatory Bowel Disease', 'orgStudyIdInfo': {'id': 'Protocol V1.4_04012024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Dye Spray Chromoendoscopy', 'description': 'Patients undergoing surveillance with dye spray chromoendoscopy', 'interventionNames': ['Procedure: Image Enhanced Endoscopy Filters']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TXI', 'description': 'Patients undergoing surveillance with TXI (Texture and Colour Enhancement Imaging)', 'interventionNames': ['Procedure: Image Enhanced Endoscopy Filters']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LCI', 'description': 'Patients undergoing surveillance with LCI (Linked Colour Imaging )', 'interventionNames': ['Procedure: Image Enhanced Endoscopy Filters']}], 'interventions': [{'name': 'Image Enhanced Endoscopy Filters', 'type': 'PROCEDURE', 'description': 'Patients that undergoing surveillance and consent to be involved in the study will be randomised to undergo surveillance with LCI, TXI or dye-spray chromoendoscopy (methylene blue).', 'armGroupLabels': ['Dye Spray Chromoendoscopy', 'LCI', 'TXI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6000', 'city': 'Perth', 'state': 'Western Australia', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Sherman Picardo, MBBS', 'role': 'CONTACT', 'phone': '92242244'}], 'facility': 'Royal Perth Hosptial', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}], 'centralContacts': [{'name': 'Sherman Picardo, MBBS (hon), MSc', 'role': 'CONTACT', 'email': 'sherman.picardo@health.wa.gov.au', 'phone': '0892242244'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Perth Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor, Principal Investigator', 'investigatorFullName': 'Sherman Picardo', 'investigatorAffiliation': 'Royal Perth Hospital'}}}}