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NCT Number: NCT07220174

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

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.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

software GI Genius™ XR on headset

Device

The screening or surveillance colonoscopy is performed with the endoscopist wearing the headset and using the software GI Genius™ XR.

Primary outcomes

  1. Adverse events

    Time frame: Day 1

    Collection and analysis of any adverse event.

  2. GI Genius™ XR critical tasks

    Time frame: Day 1

    Correct execution of critical tasks through a questionnaire

  3. Use effects

    Time frame: Day 1

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

  4. Problem resolution process

    Time frame: Day 1

    Management of non-specific problem resolution through a questionnaire.

  5. Time management

    Time frame: During the procedure

    Time to complete key tasks during the procedure.

  6. Interruption management

    Time frame: Day 1

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

  7. User feedback on usability

    Time frame: Day 1

    Thematic analysis of qualitative feedback on headset integration.

Secondary outcomes

  1. System Usability Score

    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.

Sponsors and collaborators

Lead sponsor

Cosmo Artificial Intelligence-AI Ltd

Industry

Registry information

Official study title

Pilot Usability Evaluation of GI Genius™ XR Software Running on a Virtual Reality Headset During Routine CRC Screening and Surveillance Colonoscopies

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 23, 2025
Registry last updated
Oct 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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