Linked-Color Imaging for Colon Polyps

Recruiting at 3 trial locations

Overseen By Chi-Liang Cheng, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Evergreen General Hospital, Taiwan

Must not be taking: Antithrombotics

Disqualifiers: Inflammatory bowel disease, CRC, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

1090 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for detecting colon polyps, which are small growths in the colon that could become cancerous. It compares two approaches: one uses water and artificial intelligence (AI) to identify polyps, while the other combines water, AI, and linked-color imaging (LCI) to enhance visibility. The trial aims to determine if linked-color imaging helps doctors find more significant polyps. It is designed for individuals requiring a colonoscopy due to specific symptoms like unexplained anemia or diarrhea, or a positive home stool test. Participants should not have conditions such as inflammatory bowel disease or a history of colon cancer. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future colonoscopy techniques.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this method is safe for detecting colon polyps?

A previous study showed that using water exchange (WE) colonoscopy with AI-assisted detection helped find more adenomas, which are polyps that can become cancerous. The AI technology highlights possible polyps during the procedure. Research has shown that WE colonoscopy is generally comfortable for patients, and the AI aids in finding more polyps without adding extra risk.

When WE is combined with AI and linked-color imaging (LCI), studies suggest it remains just as safe. LCI enhances visibility of the colon lining, aiding in spotting abnormalities. Using LCI with AI helps find more polyps, similar to using AI alone. Adding LCI does not seem to increase side effects or discomfort beyond what is expected with a regular colonoscopy.

Both methods, using WE with AI and WE with AI plus LCI, are considered safe. Various studies have used these techniques to improve adenoma detection without significant issues, suggesting they are well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these techniques for detecting colon polyps because they incorporate AI-assisted detection with water exchange colonoscopy, and one technique even adds Linked-Color Imaging (LCI). Traditional colonoscopy relies heavily on the endoscopist’s skill alone, but these methods enhance the process by using AI to help identify polyps in real-time, potentially increasing detection rates. LCI further boosts this by improving the visibility of subtle changes in tissue color, which can highlight polyps that might otherwise be missed. This combination of technologies could make colonoscopy more effective and efficient, potentially leading to earlier detection and better outcomes for patients.

What evidence suggests that this trial's treatments could be effective for detecting clinically significant serrated lesions?

This trial will compare two methods: Water Exchange with AI-assisted detection, and Water Exchange with AI-assisted detection and LCI. Studies have shown that AI-assisted colonoscopy helps doctors find more polyps than traditional methods. Using water instead of air to inflate the colon cleans the bowel and reduces errors. The arm using Water Exchange with AI-assisted detection and LCI may further enhance detection by highlighting differences in tissue color. Research suggests this combination could better identify important serrated lesions, leading to more accurate and thorough screenings. ^{1 2 6 7 8}

Who Is on the Research Team?

Chi-Liang Cheng, MD

Principal Investigator

Evergreen General Hospital, Taoyuan

Rungsun Rerknimitr, MD

Principal Investigator

Center of Excellence for Innovation and Endoscopy in Gastrointestinal Oncology, King Chulalongkorn Memorial Hospital

Daniel von Renteln, MD

Principal Investigator

Research, Gastroenterology Division, University of Montreal Medical Center (CHUM)

Franco Radaelli, MD

Principal Investigator

Gastroenterology Unit, Ospedale Valduce

Are You a Good Fit for This Trial?

This trial is for individuals undergoing colonoscopy for screening, surveillance, diagnosis of symptoms, or due to a positive fecal blood test. Participants should be suitable for water exchange (WE) colonoscopy and willing to potentially receive AI-assisted detection with or without linked-color imaging (LCI).

Inclusion Criteria

I am between 40-80 years old and scheduled for a colonoscopy for screening or symptoms.

Exclusion Criteria

I have had colorectal cancer in the past.

I have a history of inflammatory bowel disease.

American Society of Anesthesiology classification of physical status >3

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo water exchange colonoscopy with AI-assisted detection, with or without linked-color imaging

1 day

1 visit (in-person)

Follow-up

Participants are monitored for detection rates of clinically significant serrated lesions and other outcomes

1 week

1 visit (virtual or in-person for results discussion)

What Are the Treatments Tested in This Trial?

Interventions

• Water Exchange with AI-assisted detection
• Water Exchange with AI-assisted detection and LCI

Trial Overview The study compares two methods during WE colonoscopy: one using AI-assisted detection alone and the other combining AI with LCI technology. The goal is to see if adding LCI improves the rate of detecting clinically significant serrated lesions.

How Is the Trial Designed?

Group I: Water exchange with AI-assisted detection and LCI Experimental Treatment 1 Intervention

The study employs high-definition colonoscopy video processors with integrated CADe (CAD-EYE, EW10-EC02, Fujifilm) and LCI systems (Fujifilm).The ELUXEO 7000 system will be used . During the insertion phase of water exchange (WE) colonoscopy, the air pump will be turned off, and the colon will be irrigated with warm water, using a flushing pump. WE involves simultaneous infusion of distilled water to facilitate luminal expansion and suction of unclean water. Withdrawal will begin with the patient in the left lateral position. Consistent techniques, ensuring adequate luminal distention and comprehensive fold examination, will be used. The CADe and LCI devices will be activated during the withdrawal phase of the procedures, and it will provide real-time output in the form of a bounding box whenever the CADe device identifies a suspected polyp. All participating endoscopists possess experience and expertise in CADe and LCI systems, ensuring readiness before study initiation.

Group II: Water exchange with AI-assisted detection Active Control 1 Intervention

The study employs standard high-definition colonoscopy video processors with integrated CADe system (CAD-EYE, EW10-EC02, Fujifilm) The ELUXEO 7000 system (Fujifilm) will be used in this study. During the insertion phase of water exchange (WE) colonoscopy, the air pump will be turned off, and the colon will be irrigated with warm water, using a flushing pump. WE involves simultaneous infusion of distilled water to facilitate luminal expansion and suction of unclean water. Withdrawal will begin with the patient in the left lateral position. Consistent techniques, ensuring adequate luminal distention and comprehensive fold examination, will be used. The CADe device will be activated during the withdrawal phase of the procedures, and it will provide real-time output in the form of a bounding box whenever the CADe device identifies a suspected polyp. All participating endoscopists possess experience and expertise in CADe systems, ensuring readiness before study initiation.

Who Is Running the Clinical Trial?

Evergreen General Hospital, Taiwan

Lead Sponsor

Trials

10

Recruited

6,600+

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborator

Trials

389

Recruited

143,000+

King Chulalongkorn Memorial Hospital

Collaborator

Trials

62

Recruited

236,000+

Ospedale Valduce, Como

Collaborator

Trials

3

Recruited

3,600+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8059458/

A review of water exchange and artificial intelligence in ... AI has demonstrated high sensitivity of 90%–98.8% for polyp and adenoma detection, but its use may be limited by high false-positive rate and “ ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1091255X23011848

Artificial Intelligence-Assisted Colonoscopy for Detection of ... In this study, we found that AI-assisted colonoscopy could significantly increase the number of polyps detected compared with traditional colonoscopy, and the ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06173258

Water Exchange Colonoscopy With Artificial Intelligence ... The goal of this clinical trial is to compare the detected adenoma per colonoscopy (APC) in participants undergoing screening, surveillance, and positive ...

4. link.springer.com link.springer.com/article/10.1007/s00384-025-04949-z

Effectiveness of artificial intelligence-assisted colonoscopy ... The results showed that different adjuvant interventions had significant differences in the detection rate of adenoma compared with routine ...

5. giejournal.org giejournal.org/article/S0016-5107(22)00168-7/fulltext

Artificial intelligence complemented by water exchange for ... In this study, the use of WE not only increased APDR but also reduced FPs resulting from feces and air bubbles. This synergy between CADe and WE ...

6. trialx.com trialx.com/clinical-trials/listings/263477/water-exchange-colonoscopy-with-artificial-intelligence-assisted-detection/

Water Exchange Colonoscopy With Artificial Intelligence ... Overview. The goal of this clinical trial is to compare the detected adenoma per colonoscopy (APC) in participants undergoing screening, ...

7. wjgnet.com wjgnet.com/1007-9327/full/v31/i40/111499

Enhancing quality indicators for optimal patient outcomes AI-assisted colonoscopy improves lesion detection throughout the colon; yet meta-analyses report limited improvement in the ascending colon ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2589004225012416

Comprehensive application of artificial intelligence in ... This model leverages routine blood test results to identify individuals at high risk for precancerous polyps and rectal cancer. Some studies ...