Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2026-02-27 @ 12:49 AM
Study NCT ID:
NCT02043327
Status:
COMPLETED
Last Update Posted:
2014-01-23
First Post:
2014-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Simulation Based Training in Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012933', 'term': 'Social Identification'}], 'ancestors': [{'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-21', 'studyFirstSubmitDate': '2014-01-10', 'studyFirstSubmitQcDate': '2014-01-21', 'lastUpdatePostDateStruct': {'date': '2014-01-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Metrics with discriminatory ability measuring colonoscopy competence', 'timeFrame': 'tests were carried out in one day per participant', 'description': 'Each participant perform two tests on each model within the same day.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Colonoscopy', 'assessment', 'certification,', 'simulation,', 'standard setting'], 'conditions': ['Group Identification']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to create simulation-based tests with credible pass/fail-standards for two different fidelities of colonoscopy models\n\n1. virtual reality simulator\n2. physical model simulator To create pass/ fail standards for certification', 'detailedDescription': 'Twenty-five physicians (10 consultants with endoscopic experience and 15 fellows in the first year of fellowship without endoscopic experience) will be tested twice on each of the two different simulator models.\n\nMetrics with discriminatory ability will be identified for both modalities. Reliability will be determined A pass/ fail standard will be determined and the concequences explored.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '28 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Experienced: 10 consultants of gastroenterology with experience in Colonoscopy (\\>350 procedures) Novices: 15 fellows of gastroenterology with limited experience in Colonoscopy (\\<2 procedures)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: For the two groups\n\nExperienced endoscopists :\n\nHaving performed \\>350 colonoscopy procedures\n\nNovice endoscopists:\n\nFirst or second year of fellowship in gastroenterology Having performed less than 3 colonoscopies\n\nExclusion Criteria: For the two groups\n\nExperienced endoscopists:\n\nPrior simulator training\n\nNovice endoscopists:\n\nPrior simulator training'}, 'identificationModule': {'nctId': 'NCT02043327', 'briefTitle': 'Simulation Based Training in Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Simulation-based Training for Colonoscopy: Establishing Criteria for Competency', 'orgStudyIdInfo': {'id': 'PassFailstudy'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experienced in Colonoscopy', 'description': 'two tests on two different modalities of colonoscopy simulators'}, {'label': 'Novices in colonoscopy', 'description': 'Two tests on each of trw colonoscopy simulators'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'state': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet; CEKU', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Louise Preisler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Copenhagen, University of Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Louise Preisler', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}