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Clinical Trials in the USA / NCT07220174
Starting soon Not applicable

Use of GI Genius™ XR Software in Virtual Reality Headset During Routine Colonoscopy

NCT07220174 · tracked via the Priya Life Science USA tracker
Sponsor
Cosmo Artificial Intelligence-AI Ltd
Phase
Not applicable
Started
2025-10-31
Last updated
2025-10-23

Condition(s) studied

Colonoscopy (Procedure)

Investigational drug(s) / intervention(s)

software GI Genius™ XR on headset

software 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.

Study 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.

Eligibility

Sex
ALL
Min age
45 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • 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.
  • User feedback on usability — Day 1
    Thematic analysis of qualitative feedback on headset integration.

Trial sites (1)

FacilityCityRegionStatus
Rush University Medical Center Chicago Illinois
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07220174 on ClinicalTrials.gov ↗ ← All trials in the USA