GI Genius™ XR Software for Colonoscopy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cosmo Artificial Intelligence-AI Ltd

Disqualifiers: Heart disease, Seizures, Psychological disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new software called GI Genius™ XR, which assists doctors during colonoscopies, a procedure to check the colon for cancer. The software works with a virtual reality headset, providing a more immersive view of the video feed, potentially making it easier to identify issues. The trial seeks participants aged 45 or older who are scheduled for a routine colonoscopy. The goal is to determine if the software is easy and safe to use. As an unphased trial, it offers participants the chance to contribute to innovative research that could improve colonoscopy procedures.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What prior data suggests that the GI Genius™ XR Software is safe for use in colonoscopy procedures?

Research has shown that the GI Genius™ system, which operates with the XR software, helps find polyps during colonoscopies. The GI Genius™ is the first tool of its kind, using artificial intelligence to identify unusual areas in the colon. The FDA has approved it, confirming its safety for its intended use.

While researchers test the GI Genius™ XR software for safety and ease of use in a virtual reality setting, confidence in the technology remains high due to its existing use in medical settings. No specific negative effects have been reported for the XR software, but its connection to the approved GI Genius™ system provides reassurance about its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the GI Genius™ XR Software for colonoscopy because it represents a leap forward in how doctors can detect colon polyps. Unlike traditional colonoscopy procedures, which rely solely on the endoscopist's experience and eyesight, this software uses advanced artificial intelligence to assist in identifying potentially cancerous polyps in real-time. By incorporating AI with a headset, the software enhances the accuracy and efficiency of the procedure, potentially leading to earlier detection and better patient outcomes. This innovative approach could significantly improve the standard care for colon cancer screening, which traditionally relies on the physician's judgment alone.

What evidence suggests that the GI Genius™ XR Software is effective for colonoscopy?

Research shows that the GI Genius™ system, used by participants in this trial, can significantly enhance adenoma detection during colonoscopies. Studies have found that this system reduces missed colorectal polyps by 50% compared to standard methods. It helps identify more small and hard-to-see growths in the colon and improves the detection of certain abnormal tissues. This software aids doctors in identifying issues earlier, potentially leading to better health outcomes for patients. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals undergoing routine screening and surveillance colonoscopy procedures. Specific eligibility criteria are not provided, but typically participants would need to be suitable candidates for a colonoscopy.

Inclusion Criteria

I am scheduled for a routine colonoscopy for CRC screening or surveillance.

Written informed consent to participate (patient)

Male or female board-certified gastroenterologists experienced with CRC screening and surveillance colonoscopy

Exclusion Criteria

I am at risk of falling.

Not able to comply with the protocol requirement (patient)

Implanted or worn medical device (pacemaker, defibrillator, insulin pump, etc.) (patient)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

Treatment

Endoscopists use the GI Genius™ XR software in a virtual reality headset during routine colonoscopy procedures

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• GI Genius™ XR Software

Trial Overview The study tests the GI Genius™ XR software used in an Apple Vision Pro™ virtual reality headset during colonoscopies. It aims to see if viewing the procedure through VR can match traditional methods in terms of usability and safety.

How Is the Trial Designed?

Group I: Endoscopist with software GI Genius™ XR in headset Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Cosmo Artificial Intelligence-AI Ltd

Lead Sponsor

Trials

3

Recruited

2,400+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10235593/

Cost-effectiveness of Artificial Intelligence-Aided ... Artificial intelligence-aided colonoscopy significantly improves adenoma detection. We assessed the cost-effectiveness of the GI Genius ...

2. cureus.com cureus.com/articles/424737-effectiveness-of-the-gi-genius-computer-aided-detection-system-versus-standard-colonoscopy-a-systematic-review-and-meta-analysis-of-randomized-controlled-trials

Effectiveness of the GI Genius Computer-Aided Detection ... Pooled analysis demonstrated a statistically significant improvement in adenoma detection with GI Genius compared with standard colonoscopy (SMD ...

3. news.medtronic.com news.medtronic.com/2022-03-16-First-U-S-trial-using-GI-Genius-TM-intelligent-endoscopy-module-shows-50-reduction-in-missed-colorectal-polyps-with-artificial-intelligence-AI-technology-versus-standard-colonoscopy

First U.S. trial using GI Genius™ intelligent endoscopy ... First U.S. trial using GI Genius™ intelligent endoscopy module shows 50% reduction in missed colorectal polyps with artificial intelligence (AI) ...

4. e-ce.org e-ce.org/journal/view.php?number=7973

GI Genius increases small and right-sided adenoma and ... Outcomes included the adenomas per colonoscopy (APC), sessile serrated lesions per colonoscopy, adenoma detection rate (ADR), sessile serrated ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39153491/

Polyp detection with colonoscopy assisted by the GI ... Results of the COLO-DETECT trial support the use of GI Genius to increase detection of premalignant colorectal polyps in routine colonoscopy practice.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07220174

Use of GI Genius™ XR Software in Virtual Reality Headset ... 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 ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN200055.pdf

den200055 summary - accessdata.fda.gov Training of the GI Genius AI software was done on a subset of videos in which polyps were identified, either in the presence or absence of methylene blue. To ...

8. medtronic.com medtronic.com/en-us/healthcare-professionals/products/digestive-gastrointestinal/gastrointestinal-artificial-intelligence/gi-genius-intelligent-endoscopy-module.html

GI Genius™ Intelligent Endoscopy Module The GI Genius™ intelligent endoscopy module is the first-to-market, computer-aided polyp detection system powered by artificial intelligence.

9. withpower.com withpower.com/trial/phase-colonoscopy-procedure-9-2025-d0633

GI Genius™ XR Software for Colonoscopy 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 ...

10. pennmedicine.org pennmedicine.org/physicians-hub/physician-article/the-next-big-think-artificial-intelligence-arrives-at-penn-gastroenterology

The next big think: AI at Penn Gastroenterology Study results illustrated that colonoscopy utilizing GI Genius™ was able to identify pathology-confirmed adenomas or carcinomas in 55.1 percent ...