Use of GI Genius™ XR Software in Virtual Reality Headset During Routine Colonoscopy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: software GI Genius™ XR on headset.
- Who it may be relevant to
- Registry conditions: Colonoscopy (Procedure). Basic parameters: from 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pilot Usability Evaluation of GI Genius™ XR Software Running on a Virtual Reality Headset During Routine CRC Screening and Surveillance Colonoscopies
Overview
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.
Interventions
- Device software GI Genius™ XR on headset
The screening or surveillance colonoscopy is performed with the endoscopist wearing the headset and using the software GI Genius™ XR.
Primary outcome measures
- Adverse events [Time frame: Day 1]
- GI Genius™ XR critical tasks [Time frame: Day 1]
- Use effects [Time frame: Day 1]
- Problem resolution process [Time frame: Day 1]
- Time management [Time frame: During the procedure]
- Interruption management [Time frame: Day 1]
- User feedback on usability [Time frame: Day 1]
Secondary outcome measures (1)
- System Usability Score [Time frame: Through study completion, an average of 3 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Rush University Medical Center — Chicago
Identifiers
NCT: NCT07220174 · CB-30-08/01