Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT02778451
Status:
COMPLETED
Last Update Posted:
2016-05-19
First Post:
2016-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Certification Standards and Diagnostic Accuracy for Surgeon-performed Ultrasonography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-18', 'studyFirstSubmitDate': '2016-04-08', 'studyFirstSubmitQcDate': '2016-05-18', 'lastUpdatePostDateStruct': {'date': '2016-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Competence score on a generic skills assessment scale (The Objective Structured Assessment of Ultrasound Skills (OSAUS))', 'timeFrame': 'up to 24 months', 'description': 'Performance were video-recorded Maj 25, 2013 and afterwards assessed by a consultant in diagnostic radiology and a consultant in head and neck surgery'}], 'secondaryOutcomes': [{'measure': 'Diagnostic accuracy assessed by a head and neck surgeon reading the ultrasonography report', 'timeFrame': 'up to 24 months', 'description': 'Assessed by a head and neck surgeon reading the ultrasonography report of the participating physicians from the experimental study conducted Maj 25, 2013'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ultrasonography Skills']}, 'descriptionModule': {'briefSummary': 'Ultrasonography (US) is an operator depended image modality that is difficult to reproduce and interpret by others. Competence of the US operator is crucial for reliable diagnostics but no evidence-based certification of head and neck US skills has been developed. Investigators conducted an experimental study aimed to explore diagnostic accuracy and establish validity evidence for certification standards in surgeon-performed ultrasonography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '48 Years', 'minimumAge': '26 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '1. Ultrasonography-experienced surgeons\n\n Inclusion Criteria:\n * Board certified otolaryngologist\n * Daily use of head and neck Ultrasonography\n2. Ultrasonography novices:\n\nInclusion Criteria:\n\n* Medical doctor during internship\n\nExclusion Criteria:\n\n* experience with head and neck Ultrasonography\n* experience with head and neck surgery'}, 'identificationModule': {'nctId': 'NCT02778451', 'briefTitle': 'Certification Standards and Diagnostic Accuracy for Surgeon-performed Ultrasonography', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Certification Standards and Diagnostic Accuracy for Surgeon-performed Ultrasonography', 'orgStudyIdInfo': {'id': 'H-3-2013-081'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Ultrasonography-experienced surgeons', 'description': 'Attending physicians and consultants in head and neck surgery using head and neck Ultrasonography on a daily basis.', 'interventionNames': ['Other: Measurement of competence']}, {'type': 'OTHER', 'label': 'Ultrasonography novices', 'description': 'Physicians participating in their one-year internship at other surgical or medical departments with no experience with head and neck US or head and neck surgery.', 'interventionNames': ['Other: Measurement of competence']}], 'interventions': [{'name': 'Measurement of competence', 'type': 'OTHER', 'description': 'This study is a psychometric validation of a generic assessment tool to evaluate ultrasonography competence among surgeons', 'armGroupLabels': ['Ultrasonography novices', 'Ultrasonography-experienced surgeons']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Tobias Todsen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}