Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-05 @ 5:42 AM
Study NCT ID:
NCT01924494
Status:
COMPLETED
Last Update Posted:
2013-08-16
First Post:
2012-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gastro Intestinal Tele Endoscopy Project
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': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-15', 'studyFirstSubmitDate': '2012-08-16', 'studyFirstSubmitQcDate': '2013-08-15', 'lastUpdatePostDateStruct': {'date': '2013-08-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the potential network (LAN +WAN) limitations for video transmission image quality and audio transmission (two-way) quality.', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Validate the tele-endoscopy technology for consulting and second opinion in diagnostic endoscopy and therapeutic endoscopy (teaching, training and supervision of basic and advanced therapeutic procedures).', 'timeFrame': '2 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['telemedicine, tele-endoscopy'], 'conditions': ['Investigate the Potential Network Limitations', 'Validate the Technology for Later Clinical Use', 'Evaluate System Integration of EndoAlpha']}, 'descriptionModule': {'briefSummary': 'Synchronous Tele-Endoscopy: A clinical feasibility study of gastrointestinal tele-endoscopy by implementing and evaluating synchronous tele-endoscopy using ENDOALPHA in a hospital based endoscopy unit. EndoAlpha will be used on the hospitals existing Intranet/LAN and the possibilities of tele-endoscopy on WAN through existing network, on separate dedicated line or through new established transmission lines, will be evaluated. The EndoAlpha system will be integrated in a highly advanced endoscopy procedure room. The system will integrate through LAN with doctor office, clinic conference and lecture room and GI pathologist room. Through either LAN or WAN, connection will be establish to a referral GI center in Denmark. Through WAN, connection will be established to doctor home and to an expert Spanish center.', 'detailedDescription': 'Evaluate the potential network (LAN +WAN) limitations for video transmission image quality and audio transmission (two-way) quality. Validate the tele-endoscopy technology for consulting and second opinion in diagnostic endoscopy and therapeutic endoscopy (teaching, training and supervision of basic and advanced therapeutic procedures).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing elective gastrointestinal endoscopy procedures', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for elective gastrointestinal endoscopic procedures\n\nExclusion Criteria:\n\n* Age \\< 18 years or \\> 90 years\n* Unwilling to participate (no informed consent)\n* Not able to understand and read Danish\n* Emergency endoscopic procedures'}, 'identificationModule': {'nctId': 'NCT01924494', 'briefTitle': 'Gastro Intestinal Tele Endoscopy Project', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'Gastrointestinal Tele-Endoscopy Project: Synchronous Tele-Endoscopy - A Clinical Feasibility Study of Implementation of EndoAlpha Platform in Gastrointestinal Endoscopy.', 'orgStudyIdInfo': {'id': 'GITEP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Endoscopy procedures', 'description': 'Patients undergoing elective flexible gastrointestinal endoscopy procedures'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Endoscopy Unit, Bispebjerg Hospiatl', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant, Head of GI Endoscopy Unit', 'investigatorFullName': 'Soren Meisner', 'investigatorAffiliation': 'Bispebjerg Hospital'}}}}