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

NCT ID: NCT07220174

Last Updated: 2025-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Colonoscopy (Procedure)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Endoscopist with software GI Genius™ XR in headset

Group Type EXPERIMENTAL

software GI Genius™ XR on headset

Intervention Type DEVICE

The screening or surveillance colonoscopy is performed with the endoscopist wearing the headset and using the software GI Genius™ XR.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cosmo Artificial Intelligence-AI Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rush University Medical Center

Chicago, Illinois, United States

Site Status

Countries

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United States

Facility Contacts

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Ajaypal Singh, MD

Role: primary

312-942-8651

Other Identifiers

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CB-30-08/01

Identifier Type: -

Identifier Source: org_study_id

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