[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609868":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":37,"studyPopulation":37,"armGroups":44,"interventions":50,"overallOfficials":37,"centralContacts":37,"locations":56,"responsibleParty":76,"collaborators":37,"id":78,"slug":37,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":37,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":37,"enrollmentInfo":87,"targetDuration":37,"studyType":90,"phases":91,"briefSummary":92,"conditions":93,"keywords":37,"overallStatus":95,"whyStopped":37,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},{"fullName":5,"class":6},"Cosmo Pharmaceuticals NV","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":32,"otherOutcomes":37},[9,13,16,19,22,26,29],{"measure":10,"description":11,"timeFrame":12},"Adverse events","Collection and analysis of any adverse event.","Day 1",{"measure":14,"description":15,"timeFrame":12},"GI Genius™ XR critical tasks","Correct execution of critical tasks through a questionnaire",{"measure":17,"description":18,"timeFrame":12},"Use effects","Use effects of the virtual reality headset on endoscopists through a questionnaire.",{"measure":20,"description":21,"timeFrame":12},"Problem resolution process","Management of non-specific problem resolution through a questionnaire.",{"measure":23,"description":24,"timeFrame":25},"Time management","Time to complete key tasks during the procedure.","During the procedure",{"measure":27,"description":28,"timeFrame":12},"Interruption management","Number and severity of interruptions related to headset messages or other user device interactions.",{"measure":30,"description":31,"timeFrame":12},"User feedback on usability","Thematic analysis of qualitative feedback on headset integration.",[33],{"measure":34,"description":35,"timeFrame":36},"System Usability Score","System Usability Score questionnaire across all participating endoscopists on a \\[0-100\\] scale, where 100 is the maximum positive outcome.","Through study completion, an average of 3 months",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":37,"primaryPurpose":41,"observationalModel":37,"timePerspective":37,"maskingInfo":42},"NA","SINGLE_GROUP","OTHER",{"masking":43,"maskingDescription":37,"whoMasked":37},"NONE",[45],{"label":46,"type":47,"description":37,"interventionNames":48},"Endoscopist with software GI Genius™ XR in headset","EXPERIMENTAL",[49],"Device: software GI Genius™ XR on headset",[51],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":37},"DEVICE","software GI Genius™ XR on headset","The screening or surveillance colonoscopy is performed with the endoscopist wearing the headset and using the software GI Genius™ XR.",[46],[57],{"facility":58,"status":37,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Rush University Medical Center","Chicago","Illinois","60607","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-87.65005,41.85003,{"lat":68,"lon":67},[71],{"name":72,"role":73,"phone":74,"phoneExt":37,"email":75},"Ajaypal Singh, MD","CONTACT","312-942-8651","Ajaypal_Singh@rush.edu",{"type":77,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100609868",false,"NCT07220174","Use of GI Genius™ XR Software in Virtual Reality Headset During Routine Colonoscopy","Pilot Usability Evaluation of GI Genius™ XR Software Running on a Virtual Reality Headset During Routine CRC Screening and Surveillance Colonoscopies","Inclusion Criteria for patient:\n\n* Male or female aged ≥ 45 years;\n* Scheduled for routine CRC screening or surveillance colonoscopy;\n* Written informed consent to participate.\n\nInclusion Criteria for endoscopist:\n\n* Male or female board-certified gastroenterologists experienced with CRC screening and surveillance colonoscopy;\n* Written informed consent to participate.\n\nExclusion Criteria for patient:\n\n* Not able to comply with the protocol requirement;\n* Implanted or worn medical device (pacemaker, defibrillator, insulin pump, etc.).\n\nExclusion Criteria for endoscopist:\n\n* Not able to comply with the protocol requirement;\n* Implanted or worn medical device (pacemaker, defibrillator, insulin pump, etc.);\n* Risk of falls;\n* Seizures;\n* Heart disease;\n* Pregnant;\n* Migraines;\n* Eye or vision disorder;\n* Inner ear disorder;\n* Psychological disorder.",true,"ALL","45 Years",{"count":88,"type":89},15,"ESTIMATED","INTERVENTIONAL",[39],"This pilot study will evaluate the usability and safety of software GI Genius™ XR in the Apple Vision Pro™ virtual reality headset when used in conjunction with the GI Genius™ system during routine screening and surveillance colonoscopy procedures. GI Genius™ XR enables colonoscopists to view the standard live endoscopic video feed within a virtual reality environment as an alternative to the conventional endoscopy tower display. The system provides a virtual screen that mirrors the tower video output without any image analysis or interpretation, allowing users to adjust screen size and position for optimal visualization and situational awareness.",[94],"Colonoscopy (Procedure)","NOT_YET_RECRUITING","2025-10-21",{"date":98,"type":99},"2025-10-23","ACTUAL",{"date":101,"type":89},"2025-10-31",{"date":103,"type":89},"2026-04",{"name":105,"class":6},"Cosmo Artificial Intelligence-AI Ltd",1]