Endocuff + GI Genius for Colon Cancer Detection

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Marshall University

Must not be taking: Anti-thrombotics

Disqualifiers: Inflammatory bowel disease, Pregnancy, 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 aims to determine if using two devices together can improve the detection of colon polyps during a colonoscopy. The Endocuff attaches to the colonoscope to help spot polyps, while the GI Genius uses computer technology to assist in finding them. The study compares the use of both devices simultaneously with the use of the GI Genius alone. It involves patients scheduled for a routine colonoscopy to check for colon issues. As an unphased trial, this study allows patients to contribute to research that could enhance the effectiveness of colonoscopies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude patients on continuous anti-thrombotic therapy. It's best to discuss your specific medications with the trial team.

What prior data suggests that the Endocuff and CADe system are safe for colonoscopy procedures?

Research shows that both Endocuff and GI Genius are safe and effective for finding polyps during colonoscopies. Studies have found that Endocuff, a device attached to the colonoscope, helps spot small growths. GI Genius, an artificial intelligence system, also improves the detection of adenomas, a type of polyp.

Previous research reports that patients tolerate both technologies well, with no major side effects during colonoscopies. This suggests that using Endocuff and GI Genius together is likely safe for participants, as each has demonstrated safety in earlier studies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Endocuff + GI Genius system for colon cancer detection because it offers a novel approach to identifying polyps. Unlike standard colonoscopies, which rely solely on a doctor's visual assessment, this system uses Endocuff, an attachment that improves the view of the colon, combined with GI Genius, an AI-powered computer-aided detection (CADe) system. This combination enhances the ability to spot polyps that might otherwise be missed. The integration of AI technology in GI Genius is particularly promising as it can potentially lead to earlier and more accurate detection of colon cancer, improving patient outcomes.

What evidence suggests that this trial's treatments could be effective for colon cancer detection?

This trial will compare the effectiveness of using Endocuff with the GI Genius system versus the GI Genius system alone for detecting small growths, called adenomas, and other problem areas in the colon. Research has shown that combining Endocuff with the GI Genius system greatly improves detection rates. One study found that the combination detected adenomas 60% of the time, compared to 37% with the GI Genius alone. This suggests that adding Endocuff helps spot polyps that might otherwise be missed. In short, strong evidence indicates that using both tools together is more effective at finding potential cancerous growths during colonoscopies. ^{1 6 7 8 9}

Who Is on the Research Team?

Wesam Frandah, MD

Principal Investigator

Marshall University Joan C. Edwards School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are due for a routine outpatient colonoscopy to screen or monitor for colorectal cancer. It's not suitable for pregnant individuals, those with severe colitis, bowel obstructions, history of colon surgery, hereditary polyposis syndrome, untreated colon cancer or on continuous anti-thrombotic therapy.

Inclusion Criteria

I am older than 18 years.

I am scheduled for a routine colonoscopy check.

Exclusion Criteria

Pregnancy

You need a special procedure called deep ileal intubation.

I have a narrowing in my colon.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo colonoscopy procedures using either the Endocuff with CADe or CADe alone for colorectal cancer screening and surveillance

1 day

1 visit (in-person)

Follow-up

Participants are monitored for adenoma detection rate and safety after the colonoscopy procedure

18 months

What Are the Treatments Tested in This Trial?

Interventions

• CADe
• Endocuff

Trial Overview The study tests if adding an Endocuff device to the GI Genius computer-aided detection system improves polyp detection during a colonoscopy compared to using GI Genius alone. The goal is to see if this combination leads to better screening outcomes.

How Is the Trial Designed?

Group I: Endocuff + GI Genius Experimental Treatment 1 Intervention

Endocuff is a polyp-detecting colonoscope attachment device. GI Genius is and Computer-Aid Detection (CADe) system to detect polyps

Group II: GI Genius Active Control 1 Intervention

GI Genius is and Computer-Aid Detection (CADe) system to detect polyps

Who Is Running the Clinical Trial?

Marshall University

Lead Sponsor

Trials

21

Recruited

3,900+

Citations

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

GI Genius increases small and right-sided adenoma and ... We found that combining GI Genius and EndoCuff results in a statistically significant increase in the detection of 1 to 5 mm adenomas and SSL; ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05594576

Comparison of the ENDOCUFF VISION® Endoscopy Cap ... This study showed encouraging results in terms of colonic adenoma detection rate (60% for the AI + cap group versus 37% for the AI alone group versus 33% for ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11528738/

comparative evaluation of endocuff with computer-aided ... Our study aimed to evaluate the effectiveness of three different colonoscopy techniques in detecting adenomas: standard colonoscopy, colonoscopy ...

4. gut.bmj.com gut.bmj.com/content/73/Suppl_1/A48.2.abstract

O78 The effect of Endocuff Vision on polyp detection during ... These data and other recent trial data suggest that EV and GIG in combination enhance detection over and above GIG in isolation. In a 4-arm comparison MED, CADe ...

5. 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 ...

6. gut.bmj.com gut.bmj.com/content/74/Suppl_3/A284.3

IDDF2025-ABS-0019 Endocuff combined with computer ... Combining Endocuff with CADe significantly improves the identification of colonic lesions, particularly the diminutive ones.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9796278/

Trial protocol for COLO‐DETECT: A randomized controlled ... COLO‐DETECT will be the first multi‐centre randomized controlled trial evaluating GI Genius™ in real world colonoscopy practice and will, uniquely, evaluate ...

8. 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 ...

9. gastrojournal.org gastrojournal.org/article/S0016-5085(23)00595-4/fulltext

Combination of Mucosa-Exposure Device and Computer ... Both computer-aided detection (CADe)-assisted and Endocuff-assisted colonoscopy have been found to increase adenoma detection.