Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT03407235
Status:
COMPLETED
Last Update Posted:
2018-10-15
First Post:
2018-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Simulating Laparoscopy With an Eye Patch
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-10', 'studyFirstSubmitDate': '2018-01-16', 'studyFirstSubmitQcDate': '2018-01-22', 'lastUpdatePostDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to completion of laparoscopic tasks.', 'timeFrame': '5 minutes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Laparoscopic Training']}, 'descriptionModule': {'briefSummary': 'Comparison of laparoscopic training simulator v use of eye patch (to simulate loss of dept perception) to investigate acquisition of laparoscopic skills.', 'detailedDescription': 'Healthy volunteers who are laparoscopic novices will perform four validated laparoscopic training exercises on both the laparoscopic computerized trainer and on a simple box trainer with an eye patch.\n\nNovices will be allowed to familiarize themselves with the laparoscopic instruments and will be shown short video clips to demonstrate tasks.\n\nThey then will have five minutes to complete each of the four tasks. They will return 1-2 weeks later to complete the same process on the alternative training method.\n\nAll participants will complete the tasks on both the computerized lap simulator and the box trainer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Laparoscopic Novices\n* 20-40 years\n* All genders\n\nExclusion Criteria:\n\n* Previous laparoscopic surgical experience'}, 'identificationModule': {'nctId': 'NCT03407235', 'acronym': 'LapACQ', 'briefTitle': 'Simulating Laparoscopy With an Eye Patch', 'organization': {'class': 'OTHER', 'fullName': 'University of Nottingham'}, 'officialTitle': 'Laparoscopic Skill Acquisition; Can the Loss of Depth Perception Associated With Laparoscopic Surgery be Adequately Simulated by an Eye Patch?', 'orgStudyIdInfo': {'id': 'LTf15082013 ammend. 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Laparoscopic Novices', 'description': 'Four laparoscopic task will be undertaken on a computerized laparoscopic trainer and box trainer with eye patch.\n\nTime to completion is recorded.', 'interventionNames': ['Device: Computerized Laparoscopic Trainer', 'Device: Box trainer with eye patch']}], 'interventions': [{'name': 'Computerized Laparoscopic Trainer', 'type': 'DEVICE', 'description': 'Gold standard laparoscopic trainer using simulated computerized equipment.', 'armGroupLabels': ['Laparoscopic Novices']}, {'name': 'Box trainer with eye patch', 'type': 'DEVICE', 'description': 'Simple, cost effective box trainer, with loss of dept perception achieved with use of eye patch', 'armGroupLabels': ['Laparoscopic Novices']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DE22 3NE', 'city': 'Derby', 'country': 'United Kingdom', 'facility': 'University Of Nottingham', 'geoPoint': {'lat': 52.92277, 'lon': -1.47663}}, {'zip': 'DE22', 'city': 'Derby', 'country': 'United Kingdom', 'facility': 'The Medical School, University of Nottingham, Royal Derby Hospital.', 'geoPoint': {'lat': 52.92277, 'lon': -1.47663}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nottingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}