Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2026-03-01 @ 3:54 PM
Study NCT ID:
NCT02665767
Status:
COMPLETED
Last Update Posted:
2016-01-28
First Post:
2016-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telementoring for Identifying the Appendix Using Telesonography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-24', 'studyFirstSubmitDate': '2016-01-20', 'studyFirstSubmitQcDate': '2016-01-24', 'lastUpdatePostDateStruct': {'date': '2016-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate', 'timeFrame': '8 months', 'description': '"Success" is meaning of identifying appendix in 10 minutes.'}], 'secondaryOutcomes': [{'measure': 'Time to identifying appendix', 'timeFrame': '8 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Telesonography, Appendix'], 'conditions': ['Appendix, Ultrasonography']}, 'descriptionModule': {'briefSummary': 'The investigators investigated the feasibility of the clinical application of novice-practitioner-performed/offsite-mentor-guided ultrasonography for identifying the appendix.', 'detailedDescription': "A randomized cross-over study was conducted using a telesonography system that can transmit the ultrasound images displayed on the ultrasound monitor(ultrasound sequence video) and images showing the practitioner's operations(background video) to a smartphone without any interruption in motion over a Long Term Evolution (LTE) network. Thirty novice practitioners were randomly assigned to two groups. The subjects in group A (n=15) performed ultrasonography for the identification of the appendix under mentoring by an onsite expert, whereas those in group B (n=15) performed the same procedure under mentoring by an offsite expert.\n\nEach subject performed the procedure on three simulated patients. After a four-week interval, they performed the procedure again under the other type of mentoring. A total of 90 ultrasound examinations were performed in each scenario. The primary outcomes were the success rate for identifying the appendix and the time required to identify the appendix."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Without any experience in ultrasonography\n\nExclusion Criteria:\n\n* Subjects who do not want to participate\n* Subjects who has eye pain or any eye problem\n* Subjects who has wrist pain'}, 'identificationModule': {'nctId': 'NCT02665767', 'acronym': 'TIAT', 'briefTitle': 'Telementoring for Identifying the Appendix Using Telesonography', 'organization': {'class': 'OTHER', 'fullName': 'Hanyang University'}, 'officialTitle': 'A Feasibility Study of Telementoring for Identifying the Appendix Using Smartphone-based Telesonography', 'orgStudyIdInfo': {'id': 'Hanyang University'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'On-site sonography', 'description': 'The subjects(n=15) performed ultrasonography for the identification of the appendix under mentoring by an onsite expert.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Smartphone-based Telesonography', 'description': 'The subjects(n=15) performed ultrasonography for the identification of the appendix under mentoring by an offsite expert.', 'interventionNames': ['Device: Smartphone-based Telesonography']}], 'interventions': [{'name': 'Smartphone-based Telesonography', 'type': 'DEVICE', 'description': 'The 30 participating examiners were randomly divided into two groups. In phase one, group A performed ultrasonography under onsite mentoring and group B performed the same procedure under remote mentoring. Each examiner was randomly assigned one expert and three SPs for phase one. Four weeks later, they were partnered with the same expert and SPs to whom they had been assigned in phase one and performed the procedure under the other type of mentoring (phase two). The examination order of the SPs was randomly assigned by choosing a number between one and six (1: A-B-C, 2: A-C-B, 3: B-A-C, 4: B-C-A, 5: C-A-B, 6: C-B-A) in each phase.', 'armGroupLabels': ['Smartphone-based Telesonography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '471-701', 'city': 'Guri-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Hanyang University Guri Hospital', 'geoPoint': {'lat': 37.5986, 'lon': 127.1394}}], 'overallOfficials': [{'name': 'YOONJE LEE, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Departement of Emergency Medicine, Hanyang University Guri Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanyang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Fellowship, Emergency Medincine', 'investigatorFullName': 'LEE YOON-JE', 'investigatorAffiliation': 'Hanyang University'}}}}