Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-04 @ 6:22 PM
Study NCT ID:
NCT03118856
Status:
COMPLETED
Last Update Posted:
2019-09-26
First Post:
2017-04-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electronic Chromoendoscopy for Polyp Characterization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 230}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-25', 'studyFirstSubmitDate': '2017-04-13', 'studyFirstSubmitQcDate': '2017-04-13', 'lastUpdatePostDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of predicting histology with EC', 'timeFrame': '1 year', 'description': 'Polyps will be visualized in white-light and the location and size will be noted. Afterwards, electronic chromoendoscopy will be used to visualize and enhance the mucosal vascular pattern and the mucosal surface pattern morphology of the polyp. The endoscopist will then make a real time assessment of each polyp according to size, shape, Paris classification and surface characteristics including pit pattern and mucosal vascular pattern morphology, colour, and type of depression. Further, a level of confidence (high or low) will be made for the real time histology prediction. Finally, all polyps will be removed using standard techniques and processed for pathological evaluation and real time and histological results will be compared.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Polyp']}, 'descriptionModule': {'briefSummary': 'To assess the accuracy of predicting histology of colorectal polyps with electronic chromoendoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing screening or surveillance colonoscopy', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing screening or surveillance colonoscopy\n* written informed consent\n\nExclusion Criteria:\n\n* inadequate bowel preparation\n* polyposis syndromes\n* history of colectomy\n* use of anticoagulants'}, 'identificationModule': {'nctId': 'NCT03118856', 'briefTitle': 'Electronic Chromoendoscopy for Polyp Characterization', 'organization': {'class': 'OTHER', 'fullName': 'University of Erlangen-Nürnberg Medical School'}, 'officialTitle': 'Real-time Assessment of the Histology of Colorectal Polyps Using Electronic Chromoendoscopy', 'orgStudyIdInfo': {'id': 'TR-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HD-WLE', 'description': 'Intervention: Prediction of polyp histology with HD-WLE', 'interventionNames': ['Diagnostic Test: Prediction of Histology']}, {'label': 'EC', 'description': 'Intervention: Prediction of polyp histology with EC', 'interventionNames': ['Diagnostic Test: Prediction of Histology']}], 'interventions': [{'name': 'Prediction of Histology', 'type': 'DIAGNOSTIC_TEST', 'description': 'The accuracy of predicting the histology of colorectal polyps will be assessed with HD-WLE and EC', 'armGroupLabels': ['EC', 'HD-WLE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91054', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'University Hospital Erlangen', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}], 'overallOfficials': [{'name': 'Timo Rath, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Erlangen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Erlangen-Nürnberg Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}