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This pilot study will evaluate the usability and safety of software GI Geniusâ„¢ XR in the Apple Vision Proâ„¢ virtual reality headset when used in conjunction with the GI Geniusâ„¢ system during routine screening and surveillance colonoscopy procedures. GI Geniusâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopist with software GI Geniusâ„¢ XR in headset | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| software GI Geniusâ„¢ XR on headset | Device | The screening or surveillance colonoscopy is performed with the endoscopist wearing the headset and using the software GI Geniusâ„¢ XR. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Collection and analysis of any adverse event. | Day 1 |
| GI Geniusâ„¢ XR critical tasks | Correct execution of critical tasks through a questionnaire | Day 1 |
| Use effects | Use effects of the virtual reality headset on endoscopists through a questionnaire. | Day 1 |
| Problem resolution process | Management of non-specific problem resolution through a questionnaire. | Day 1 |
| Time management | Time to complete key tasks during the procedure. | During the procedure |
| Interruption management | Number and severity of interruptions related to headset messages or other user device interactions. | Day 1 |
| User feedback on usability | Thematic analysis of qualitative feedback on headset integration. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria for patient:
Inclusion Criteria for endoscopist:
Exclusion Criteria for patient:
Exclusion Criteria for endoscopist:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60607 | United States |
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