Pilot Usability Evaluation of GI Genius™ XR Software Running on a Virtual Reality Headset During Routine CRC Screening and Surveillance Colonoscopies
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Adverse events
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •for patient:
- •Male or female aged ≥ 45 years;
- •Scheduled for routine CRC screening or surveillance colonoscopy;
- •Written informed consent to participate.
- •Inclusion Criteria for endoscopist:
- •Male or female board-certified gastroenterologists experienced with CRC screening and surveillance colonoscopy;
- •Written informed consent to participate.
Exclusion Criteria
- •for patient:
- •Not able to comply with the protocol requirement;
- •Implanted or worn medical device (pacemaker, defibrillator, insulin pump, etc.).
- •Exclusion Criteria for endoscopist:
- •Not able to comply with the protocol requirement;
- •Implanted or worn medical device (pacemaker, defibrillator, insulin pump, etc.);
- •Risk of falls;
- •Seizures;
- •Heart disease;
- •Pregnant;
- •Migraines;
- •Eye or vision disorder;
- •Inner ear disorder;
- •Psychological disorder.
Outcomes
Primary Outcomes
Adverse events
Time Frame: Day 1
Collection and analysis of any adverse event.
GI Genius™ XR critical tasks
Time Frame: Day 1
Correct execution of critical tasks through a questionnaire
Use effects
Time Frame: Day 1
Use effects of the virtual reality headset on endoscopists through a questionnaire.
Problem resolution process
Time Frame: Day 1
Management of non-specific problem resolution through a questionnaire.
Time management
Time Frame: During the procedure
Time to complete key tasks during the procedure.
Interruption management
Time Frame: Day 1
Number and severity of interruptions related to headset messages or other user device interactions.
User feedback on usability
Time Frame: Day 1
Thematic analysis of qualitative feedback on headset integration.
Secondary Outcomes
- System Usability Score(Through study completion, an average of 3 months)