What this study is
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.
What's being tested
- software GI Genius™ XR on headset
Intervention · DEVICE
The screening or surveillance colonoscopy is performed with the endoscopist wearing the headset and using the software GI Genius™ XR.
Study details
- Official title
- Pilot Usability Evaluation of GI Genius™ XR Software Running on a Virtual Reality Headset During Routine CRC Screening and Surveillance Colonoscopies
- Sponsor
- Cosmo Artificial Intelligence-AI Ltd
- Conditions
- Colonoscopy (Procedure)
- Enrolling
- 15 people
- Starts
- 2025-10-31
- Est. completion
- 2026-04
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 45 Years and overSex ALLHealthy volunteers Acceptedpatient
You may qualify if
- Male or female aged ≥ 45 years;
- Scheduled for routine CRC screening or surveillance colonoscopy;
- Written informed consent to participate.
You can't join if
- Not able to comply with the protocol requirement;
- Implanted or worn medical device (pacemaker, defibrillator, insulin pump, etc.).
endoscopist
You may qualify if
- Male or female board-certified gastroenterologists experienced with CRC screening and surveillance colonoscopy;
- Written informed consent to participate.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openRush University Medical Center
Chicago, Illinois, United States
- Ajaypal Singh, MD · Contact312-942-8651Ajaypal_Singh@rush.edu
Study team
Sponsor
Cosmo Artificial Intelligence-AI Ltd
Study ID CB-30-08/01
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.