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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45+
SponsorCosmo Artificial Intelligence-AI Ltd

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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.);

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Endoscopist with software GI Genius™ XR in headsetExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse events

Collection and analysis of any adverse event.

Time frame
Day 1
2

GI Genius™ XR critical tasks

Correct execution of critical tasks through a questionnaire

Time frame
Day 1
3

Use effects

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

Time frame
Day 1
4

Problem resolution process

Management of non-specific problem resolution through a questionnaire.

Time frame
Day 1

Secondary outcomes

1

System Usability Score

System Usability Score questionnaire across all participating endoscopists on a \[0-100\] scale, where 100 is the maximum positive outcome.

Time frame
Through study completion, an average of 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: