Colonoscopy (Procedure)NCT07220174
Use of GI Genius™ XR Software in Virtual Reality Headset During Routine Colonoscopy
A study testing software GI Genius™ XR on headset in people with Colonoscopy (Procedure), run by Cosmo Artificial Intelligence-AI Ltd at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy (Procedure)
- What is being tested?
- software GI Genius™ XR on headset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2025to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- Heart disease;
- Pregnant;
- Migraines;
- Eye or vision disorder;
- Inner ear disorder;
- Psychological disorder.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60607
Ajaypal Singh, MD, 312-942-8651, Ajaypal_Singh@rush.edu
About this study
Official title: Pilot Usability Evaluation of GI Genius™ XR Software Running on a Virtual Reality Headset During Routine CRC Screening and Surveillance Colonoscopies
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)
- Being tested
- software GI Genius™ XR on headset
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
software GI Genius™ XR on headsetDevice
The screening or surveillance colonoscopy is performed with the endoscopist wearing the headset and using the software GI Genius™ XR.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopist with software GI Genius™ XR in headset | Experimental | Not described Receives: Device: software GI Genius™ XR on headset |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Collection and analysis of any adverse event.
Measured: Day 1
GI Genius™ XR critical tasks
Correct execution of critical tasks through a questionnaire
Measured: Day 1
Use effects
Use effects of the virtual reality headset on endoscopists through a questionnaire.
Measured: Day 1
Problem resolution process
Management of non-specific problem resolution through a questionnaire.
Measured: Day 1
Time management
Time to complete key tasks during the procedure.
Measured: During the procedure
Interruption management
Number and severity of interruptions related to headset messages or other user device interactions.
Measured: Day 1
User feedback on usability
Thematic analysis of qualitative feedback on headset integration.
Measured: 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.
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2025
- Study start31 Oct 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonoscopy (Procedure)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cosmo Artificial Intelligence-AI Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07220174
- Sponsor's protocol ID
- CB-30-08/01
- Status last verified
- Oct 2025
- First submitted
- 9 Oct 2025
- Last updated
- 23 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Usability Evaluation of GI Genius™ XR Software Running on a Virtual Reality Headset During Routine CRC Screening and Surveillance Colonoscopies
- ClinicalTrials.gov ID
- NCT07220174
- Acronym / sponsor ID
- CB-30-08/01
- Conditions
- Colonoscopy (Procedure)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Cosmo Artificial Intelligence-AI LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 23 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopist with software GI Genius™ XR in headset | Experimental | Device: software GI Genius™ XR on headset |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| software GI Genius™ XR on headsetThe screening or surveillance colonoscopy is performed with the endoscopist wearing the headset and using the software GI Genius™ XR. | Device | Endoscopist with software GI Genius™ XR in headset |
Primary outcome
Adverse events
Time frame: Day 1
Collection and analysis of any adverse event.
GI Genius™ XR critical tasks
Time frame: Day 1
Correct execution of critical tasks through a questionnaire
Use effects
Time frame: Day 1
Use effects of the virtual reality headset on endoscopists through a questionnaire.
Problem resolution process
Time frame: Day 1
Management of non-specific problem resolution through a questionnaire.
Time management
Time frame: During the procedure
Time to complete key tasks during the procedure.
Interruption management
Time frame: Day 1
Number and severity of interruptions related to headset messages or other user device interactions.
User feedback on usability
Time frame: Day 1
Thematic analysis of qualitative feedback on headset integration.
1 secondary outcome
System Usability Score
Time frame: Through study completion, an average of 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing software GI Genius™ XR on headset in people with Colonoscopy (Procedure), run by Cosmo Artificial Intelligence-AI Ltd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Day 1). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2025.