Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT03891251
Status:
RECRUITING
Last Update Posted:
2025-10-06
First Post:
2019-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Collecting Recorded Videos of Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003111', 'term': 'Colonic Polyps'}], 'ancestors': [{'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2019-03-09', 'studyFirstSubmitQcDate': '2019-03-23', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recorded colonoscopy video which was verified by visual inspection to have sufficient high quality.', 'timeFrame': 'Half an hour from the end of the procedure at which the video was recorded.', 'description': 'Each recorded video is visually inspected immediately at the end of the procedure by an experienced team member who rates it with a number between 1 (the lowest quality) to 10 (the highest quality). This is a quality scale which indicates the general quality of the recorded video. Only videos with rate above 7 are considered as having sufficient high quality that enables to use them and analyze them.'}, {'measure': 'De-Identified procedure report which was visually inspected to verify that it includes all the needed details about the polyps that were detected during the procedure.', 'timeFrame': 'Half an hour from the end of the procedure for which the procedure report was filled-in.', 'description': 'Each de-Identified procedure report is visually inspected immediately at the end of the procedure by an experienced team member who gives it binary score (0 or 1), 1 if it includes all the needed details about the polyps that were detected during the procedure, and 0 if does not include all the needed details about the polyps that were detected during the procedure. Only procedure reports which get the value of 1 can be used for full analysis of the recorded procedure.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colon Polyp']}, 'descriptionModule': {'briefSummary': 'The study shall mainly help to better evaluate the performance the APDS device and secondly it may help to assess the potential of the future alpha version of the device to be a useful and effective for the detection of colon Polyps.', 'detailedDescription': 'Primary objectives • To evaluate, in objective way, the usability of the future alpha version of the APDS device by testing the sensitivity and specificity of its results achieved from running it on the collected recorded videos of Colonoscopy screening tests of the general population.\n\nSecondary objectives\n\n• When the APDS would be ready for field installation (Beta Version), to install it in the Gastroenterology institute of the medical center, in order to evaluate, as part of a continuation study, the physicians satisfaction from the APDS performance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Subjects shall be recruited by the investigator from within the investigator's patient population of colonoscopy. In this study one site will participate and enroll not less than 250 patients and up to 700 subjects according to the inclusion/exclusion criteria. Each subject (not less than 250 patients and up to 700 subjects) included will pass one regular colonoscopy screening test which will be recorded in the way which is described above.\n\nEnrolled subjects that did not complete the full course of the study will be replaced.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects must meet all the - criteria related to regular colonoscopy according to the standard of care at the Gastroenterology Department of the selected center, \\_In addition the following - criteria have to be met to be eligible for the study:\n\n1. Able to read, understand and provide written Informed Consent;\n2. Females or males - older than 18 years old\n\nExclusion Criteria:\n\nAny of the following colonoscopy related exclusion criteria will exclude the subject from the study:\n\n* Bleeding disorder or unacceptable risk of bleeding\n* Terminal illness or life threatening malignancy'}, 'identificationModule': {'nctId': 'NCT03891251', 'briefTitle': 'Collecting Recorded Videos of Colonoscopy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Magentiq Eye LTD'}, 'officialTitle': 'Collecting Recorded Videos of Colonoscopy Screening Tests for the Evaluation of the Automatic Polyp Detection System (APDS) Medical Device', 'orgStudyIdInfo': {'id': '0493-18-HMO'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Collecting recorded videos of Colonoscopy screening tests', 'type': 'OTHER', 'description': 'To evaluate, in objective way, the usability of the future alpha version of the APDS device by testing the sensitivity and specificity of its results achieved from running it on the collected recorded videos of Colonoscopy screening tests of the general population.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91120', 'city': 'Jerusalem', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Harold Jacob, MD', 'role': 'CONTACT'}], 'facility': 'Hadassah Medical Organization', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'centralContacts': [{'name': 'Dror Zur, Ph.D.', 'role': 'CONTACT', 'email': 'dror@magentiq.com', 'phone': '+972(54)7555922'}], 'overallOfficials': [{'name': 'Harold Jacob, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Senior Gastroenterologist'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Magentiq Eye LTD', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}