AI-Assisted Detection for Adenoma During Colonoscopy

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Disqualifiers: Emergency colonoscopy, Familial polyposis, Inflammatory bowel, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

1596 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new AI tool, Medtronic-GI Genius, designed to help doctors detect adenomas (a type of polyp) during colonoscopies. The goal is to determine if this tool enables doctors to find more adenomas compared to the usual method without AI assistance. Individuals undergoing a routine colonoscopy for screening or diagnostic reasons, who do not have certain known conditions like inflammatory bowel disease, may be suitable candidates. Participants will have their colonoscopy either with this AI tool or in the usual way without it. As an unphased trial, this study allows participants to contribute to innovative research that could enhance the effectiveness of colonoscopies.

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

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Medtronic-GI genius system is safe for use in colonoscopy?

Studies have shown that the Medtronic-GI Genius system, which aids in detecting polyps during colonoscopies, is generally safe. One study found that the number of unintended side effects was similar between colonoscopies using the GI Genius system and those without it, with 25 side effects in the group using the system compared to 19 in the group without it. This finding suggests that the GI Genius system does not increase the risk of side effects during colonoscopy procedures. Additionally, the FDA has approved the system for finding polyps and adenomas (a type of tumor), further supporting its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the AI-assisted detection system, Medtronic-GI genius, because it offers a new way to enhance colonoscopy procedures. Unlike traditional colonoscopies where doctors rely solely on their expertise to spot polyps, this system uses real-time artificial intelligence to highlight potential polyps on the screen with a bounding box. This could help doctors catch polyps of all sizes that might otherwise be missed, potentially leading to earlier detection and treatment of colorectal issues. By providing immediate feedback during the procedure, it aims to improve the accuracy and effectiveness of standard colonoscopies.

What evidence suggests that the Medtronic-GI genius CADe system is effective for adenoma detection during colonoscopy?

Research has shown that the Medtronic-GI Genius system can improve the detection of adenomas, potentially cancerous growths, during colonoscopies. In this trial, participants will undergo colonoscopy either with or without the Medtronic-GI Genius system. Studies have found that this system increases the detection rate by about 12% compared to standard procedures. The Medtronic-GI Genius system provides real-time alerts by highlighting polyps on the screen, helping doctors spot them more easily. Overall, it enhances the effectiveness of colonoscopies in identifying potential cancer precursors. ^{2 5 6 7 8}

Who Is on the Research Team?

Daniel von Renteln

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Are You a Good Fit for This Trial?

This trial is for people aged 45-80 who are at high risk of colorectal polyps due to a positive FIT, family or personal history of CRC, or previous polyps. They must consent to the study and need a screening or diagnostic colonoscopy. It's not for those with inflammatory bowel disease, severe coagulopathy, emergency cases, familial polyposis syndrome, or very poor health.

Inclusion Criteria

Signed informed consent

I am at high risk for colorectal polyps due to family history, personal history, or previous findings.

I am scheduled for a colonoscopy for screening, surveillance, or diagnosis.

Exclusion Criteria

I do not have inflammatory bowel disease, active colitis, severe coagulopathy, need for emergency colonoscopy, familial polyposis syndrome, or poor general health.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo colonoscopy with or without the CADe system, depending on the assigned group

1 day

1 visit (in-person)

Follow-up

Participants are monitored for adenoma detection rate and other secondary outcomes

30 days

Data Collection and Analysis

Data is collected from clinical files and endoscopy reports, deidentified, and analyzed

Through study completion, an average of 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Medtronic-GI genius

Trial Overview The trial tests if using AI (Medtronic-GI genius) during colonoscopies increases adenoma detection rates compared to standard procedures. Participants will be randomly assigned to either an AI-assisted room or a regular one without knowing which they're in (double-blind).

How Is the Trial Designed?

Group I: Operating room equipped with the CADe (Medtronic-GI genius for real-time detection) Experimental Treatment 1 Intervention

The Medtronic-GI genius (CADe) system can be used to detect polyps of all sizes. Use of CADe is left to the discretion of the treating physician performing the colonoscopy. If used CADe will provide real-time feedback throughout each colonoscopy procedure and will alert the endoscopists of the presence of a polyp in the endoscopy field by displaying a bounding box on the same screen.

Group II: Colonoscopy performed in room without CADe system Active Control 1 Intervention

In the control group (standard colonoscopy), the participating endoscopists will detect and classify colorectal lesions without using any AI modules.

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Université de Sherbrooke

Collaborator

Trials

317

Recruited

79,300+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

University of Alberta

Collaborator

Trials

957

Recruited

437,000+

McGill University

Collaborator

Trials

421

Recruited

1,017,000+

Published Research Related to This Trial

The COLO-DETECT trial will assess the effectiveness of the GI Genius™ computer-aided detection system in improving adenoma detection rates during colonoscopy, involving 1828 participants across various NHS sites in England.

This study is significant as it will be the first multi-centre randomized controlled trial to evaluate both the clinical and cost-effectiveness of GI Genius™ in routine colonoscopy practice, potentially enhancing colorectal cancer screening outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trial protocol for COLO-DETECT: A randomized controlled trial of lesion detection comparing colonoscopy assisted by the GI Genius™ artificial intelligence endoscopy module with standard colonoscopy. Seager, A., Sharp, L., Hampton, JS., et al.[2022]

The artificial intelligence system for colorectal neoplasia detection (CADe) demonstrated high sensitivity (92.9%) and accuracy (91.7%), indicating its potential to significantly enhance lesion recognition during colonoscopy.

The CADx system also showed promising results with an accuracy of 83.6%, and notably, non-expert endoscopists using CAD achieved performance levels similar to experts, although with lower specificity, suggesting that AI can help improve diagnostic capabilities in less experienced practitioners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of a new integrated computer-assisted system (CADe/CADx) for detection and characterization of colorectal neoplasia. Weigt, J., Repici, A., Antonelli, G., et al.[2022]

A study involving 33 early-career endoscopists analyzing 200 colonoscopy videos showed that using an AI tool significantly improved their ability to detect polyps, increasing sensitivity from 86.3% to 91.7%.

The AI tool also enhanced the detection of neoplastic polyps, with sensitivity rising from 85.4% to 92.1%, indicating that AI can effectively support endoscopists in identifying potentially harmful growths.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of artificial intelligence on colorectal polyp detection for early-career endoscopists: an international comparative study. Ainechi, D., Misawa, M., Barua, I., et al.[2022]

Artificial intelligence can enhance the quality of colonoscopy screenings by improving adenoma detection rates through real-time computer-assisted detection of polyps.

AI technology can also reduce unnecessary costs by enabling optical biopsies for low-risk polyps, allowing for strategies like resect-and-discard, which streamlines patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Artificial Intelligence Will Impact Colonoscopy and Colorectal Screening. Shung, DL., Byrne, MF.[2021]

Artificial intelligence, particularly through deep neural networks, has significantly improved polyp detection during colonoscopy, increasing detection rates by about 10% according to recent prospective trials.

Tandem randomized control trials demonstrated that AI assistance reduced the adenoma miss rate from 36.7% to 13.8%, indicating a substantial improvement in the accuracy of colonoscopy procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Artificial intelligence in colonoscopy: A review on the current status. Larsen, SLV., Mori, Y.[2022]

Computer-aided diagnosis in colonoscopy can significantly reduce the miss rates for polyps, which are currently as high as 22%, potentially decreasing the risk of interval colorectal cancers.

Recent advancements in artificial intelligence have led to algorithms that can match the performance of human experts in detecting and characterizing polyps, enhancing the reliability of optical biopsy techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Artificial intelligence and computer-aided diagnosis in colonoscopy: current evidence and future directions. Ahmad, OF., Soares, AS., Mazomenos, E., et al.[2019]

The GI Genius™ system, a real-time deep-learning computer-aided detection tool, has been approved by the US FDA to assist in identifying polyps during colonoscopy, addressing the issue that about 25% of colorectal cancers are missed during these procedures.

This review highlights the potential of artificial intelligence to enhance endoscopic surveillance strategies, improving the detection rates of precancerous lesions and potentially leading to better outcomes in colorectal cancer prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Discovering the first US FDA-approved computer-aided polyp detection system. Spadaccini, M., Marco, A., Franchellucci, G., et al.[2022]

In a study of 150 patients undergoing colonoscopy, an artificial intelligence (AI) system showed comparable adenoma miss rates (AMR) and adenoma detection rates (ADR) to experienced endoscopists, indicating its potential effectiveness in real-time colonoscopy.

The AI system did not significantly improve the detection of adenomas compared to routine colonoscopy, with both methods achieving high ADRs of over 50%, suggesting that while AI can assist, it may not surpass the performance of skilled endoscopists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic accuracy of a novel artificial intelligence system for adenoma detection in daily practice: a prospective nonrandomized comparative study. Zippelius, C., Alqahtani, SA., Schedel, J., et al.[2022]

GI Genius is the first AI-powered medical device for colonoscopy, showing promise in enhancing decision-making and consistency during procedures, as it has been widely tested and reviewed in the scientific community.

The device's transparent AI architecture and training methods suggest it could significantly improve the accuracy and efficiency of colonoscopy procedures, marking a major advancement in the integration of AI in medical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of the Technology, Training, and Assessment Methods for the First Real-Time AI-Enhanced Medical Device for Endoscopy. Cherubini, A., Dinh, NN.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11637665/

Assessing the potential of artificial intelligence to enhance ... This study aimed to evaluate the effectiveness of the GI Genius (Medtronic) module in clinical practice, focusing on the adenoma detection rate (ADR) during ...

2. medtronic.com medtronic.com/covidien/en-gb/products/gastrointestinal-artificial-intelligence/gi-genius-cadx-detection-analysis-prediction.html

Computer-Aided Detection. Analysis. Prediction With GI Genius™ on your endoscopy team, you will be able to detect more life-threatening cancerous lesions. This market-leading endoscopy AI technology has been ...

3. 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 ... Random-effects meta-analyses showed that GI Genius increased the adenoma detection rate (ADR) compared with standard colonoscopy (RR 1.12, 95% ...

4. medtronic.com medtronic.com/en-us/healthcare-professionals/education-training/genius-academy/physician-perspectives/computer-aided-detection-system-significantly-improves-polyp-detection.html

A computer-aided detection (CADe) system significantly ... The primary outcome of the study was the rate of polyp removal during screening and surveillance colonoscopies. Secondary outcomes included the ADR for ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05244278

Artificial Intelligence (AI) Assisted Real-time Adenoma ... The Medtronic-GI genius (CADe) system can be used to detect polyps of all sizes. Use of CADe is left to the discretion of the treating physician performing the ...

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

Polyp detection with colonoscopy assisted by the GI ... Numbers of adverse events were similar between the CADe-assisted colonoscopy and standard colonoscopy groups (adverse events: 25 vs 19; serious ...

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

den200055 summary - accessdata.fda.gov The GI Genius System is a computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal lesions (such as polyps and adenomas) in real ...

8. thelancet.com thelancet.com/journals/langas/article/PIIS2468-1253(23)00104-8/abstract

Effect of real-time computer-aided detection of colorectal ... We aimed to evaluate the effect of real-time computer-aided detection (CADe) on the adenoma detection rate (ADR) in routine colonoscopy. Methods.