Colonoscopy (Procedure)
Conditions
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.
Interventions
DEVICEsoftware 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.
Sponsors
Cosmo Artificial Intelligence-AI Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
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.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| User feedback on usability | Day 1 | Thematic analysis of qualitative feedback on headset integration. |
| Adverse events | Day 1 | Collection and analysis of any adverse event. |
| GI Genius™ XR critical tasks | Day 1 | Correct execution of critical tasks through a questionnaire |
| Use effects | Day 1 | Use effects of the virtual reality headset on endoscopists through a questionnaire. |
| Problem resolution process | Day 1 | Management of non-specific problem resolution through a questionnaire. |
| Time management | During the procedure | Time to complete key tasks during the procedure. |
| Interruption management | Day 1 | Number and severity of interruptions related to headset messages or other user device interactions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| System Usability Score | Through study completion, an average of 3 months | System Usability Score questionnaire across all participating endoscopists on a \[0-100\] scale, where 100 is the maximum positive outcome. |
Countries
United States
Outcome results
None listed