Rush University Medical Center
Chicago, Illinois, 60607, United States
NCT Number: NCT07220174
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.
Trial opening soon.
Get Notified45 year and older
All sexes
Interventional
Not applicable
Chicago, Illinois, 60607, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for patient:
Inclusion criteria
for endoscopist:
Exclusion criteria
for patient:
Exclusion criteria
for endoscopist:
The screening or surveillance colonoscopy is performed with the endoscopist wearing the headset and using the software GI Genius™ XR.
Time frame: Day 1
Collection and analysis of any adverse event.
Time frame: Day 1
Correct execution of critical tasks through a questionnaire
Time frame: Day 1
Use effects of the virtual reality headset on endoscopists through a questionnaire.
Time frame: Day 1
Management of non-specific problem resolution through a questionnaire.
Time frame: During the procedure
Time to complete key tasks during the procedure.
Time frame: Day 1
Number and severity of interruptions related to headset messages or other user device interactions.
Time frame: Day 1
Thematic analysis of qualitative feedback on headset integration.
Time frame: 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.
Cosmo Artificial Intelligence-AI Ltd
Industry
Pilot Usability Evaluation of GI Genius™ XR Software Running on a Virtual Reality Headset During Routine CRC Screening and Surveillance Colonoscopies
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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