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

NCT07220174 | Not Yet Recruiting FDA Device

• 1 other identifier: CB-30-08/01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colonoscopy (Procedure)

Outcome Measures

Primary Outcomes (7)

• Adverse events

  Collection and analysis of any adverse event.

  Day 1

• GI Genius™ 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

Secondary Outcomes (1)

• System Usability Score

  Through study completion, an average of 3 months

Study Arms (1)

Endoscopist with software GI Genius™ XR in headset

EXPERIMENTAL

Device: software GI Genius™ XR on headset

Interventions

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.

Endoscopist with software GI Genius™ XR in headset

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cosmo Artificial Intelligence-AI Ltd: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60607, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2025
• First Posted: October 23, 2025
• Study Start: October 31, 2025
• Primary Completion: January 1, 2026
• Study Completion: April 1, 2026
• Last Updated: October 23, 2025

Record last verified: 2025-10

Locations

US (1)