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

Cosmo Artificial Intelligence-AI

Status

Not yet enrolling

Conditions

Colonoscopy (Procedure)

Treatments

Device: software GI Genius™ XR on headset

Study type

Interventional

Funder types

Industry

Identifiers

NCT07220174

CB-30-08/01

Details and patient eligibility

About

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.

Enrollment

15 estimated patients

Sex

All

Ages

45+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.