About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or female aged ≥ 45 years;
Scheduled for routine CRC screening or surveillance colonoscopy;
Written informed consent to participate.
Male or female board-certified gastroenterologists experienced with CRC screening and surveillance colonoscopy;
Disqualifiers
Not able to comply with the protocol requirement;
Implanted or worn medical device (pacemaker, defibrillator, insulin pump, etc.).
Not able to comply with the protocol requirement;
Implanted or worn medical device (pacemaker, defibrillator, insulin pump, etc.);
Trial design
Single group
Treatments tested in this trial
software GI Genius™ XR on headset
DeviceThe screening or surveillance colonoscopy is performed with the endoscopist wearing the headset and using the software GI Genius™ XR.
Treatment groups
Trial outcomes
Primary outcomes
Adverse events
Collection and analysis of any adverse event.
GI Genius™ XR critical tasks
Correct execution of critical tasks through a questionnaire
Use effects
Use effects of the virtual reality headset on endoscopists through a questionnaire.
Problem resolution process
Management of non-specific problem resolution through a questionnaire.
Secondary outcomes
System Usability Score
System Usability Score questionnaire across all participating endoscopists on a \[0-100\] scale, where 100 is the maximum positive outcome.
Sponsors and contacts
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