GI Genius™ XR Software in Virtual Reality Headset for Colonoscopy

This study is looking at a new way for doctors to perform routine colonoscopies (a procedure to look inside the large intestine). It's testing the usability and safety of software called GI Genius™ XR, which is used in an Apple Vision Pro™ virtual reality headset. Instead of looking at a traditional screen, the doctor would see the live video from the colonoscopy in a virtual reality environment. This allows them to adjust the screen size and position for better viewing. The study is open to people aged 45 and older who are scheduled for a routine colonoscopy for screening or surveillance. Doctors who are board-certified gastroenterologists and experienced with colonoscopies can also participate. The main goals are to see if there are any side effects and how well the GI Genius™ XR software works and is used by doctors.

Study design
This is a pilot study, meaning it's an early-stage investigation, and plans to include 15 participants. It is an interventional study, where participants receive a specific intervention.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Adverse events, critical tasks, and use effects will be measured on Day 1.

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NCT07220174

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

Not Yet Recruiting
NAAges 45+Interventional
Cosmo Artificial Intelligence-AI Ltd
~15 participants
Updated 2025-10-23 on ClinicalTrials.gov
What's tested:software GI Genius™ XR on headset

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse events
Measured over Day 1
+6 more outcomes measured
Colonoscopy (Procedure)
1 sites across 1 states
Illinois1

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Eligibility criteria

Inclusion

Male or female aged ≥ 45 years;
Scheduled for routine CRC screening or surveillance colonoscopy;
Written informed consent to participate.
Male or female board-certified gastroenterologists experienced with CRC screening and surveillance colonoscopy;
Written informed consent to participate.

Exclusion

Not able to comply with the protocol requirement;
Implanted or worn medical device (pacemaker, defibrillator, insulin pump, etc.).
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.
  • Adverse eventsDay 1

    Collection and analysis of any adverse event.

  • GI Genius™ XR critical tasksDay 1

    Correct execution of critical tasks through a questionnaire

  • Use effectsDay 1

    Use effects of the virtual reality headset on endoscopists through a questionnaire.

  • Problem resolution processDay 1

    Management of non-specific problem resolution through a questionnaire.

  • Time managementDuring the procedure

    Time to complete key tasks during the procedure.

  • Interruption managementDay 1

    Number and severity of interruptions related to headset messages or other user device interactions.

  • User feedback on usabilityDay 1

    Thematic analysis of qualitative feedback on headset integration.