Sessile Colonic PolypNCT07127471
Computer-Aided Water Exchange Colonoscopy With and Without Linked-Color Imaging for Detection of Clinically Significant Serrated Lesions
A study testing Water exchange with AI-assisted detection and Water exchange with AI-assisted detection and LCI in people with Sessile Colonic Polyp and Serrated Lesion, run by Evergreen General Hospital, Taiwan at 4 sites in 4 countries.
Trial summary
The goal of this clinical trial is to compare the detection rate of clinically significant serrated lesions (CSSL) in participants undergoing water exchange (WE) colonoscopy with artificial intelligence (AI)-based computer-aided detection (CADe) for screening, surveillance, diagnosis for symptoms, or referred owing to… Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sessile Colonic Polyp, Serrated Lesion, Sessile Serrated Lesion
- What is being tested?
- Water exchange with AI-assisted detection and Water exchange with AI-assisted detection and LCI
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,090 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 17 Nov 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female patients aged 40-80 years scheduled for average-risk screening colonoscopy, post-polypectomy surveillance, diagnosis for gastrointestinal symptoms (including unexplained iron deficiency anemia and clinically significant diarrhea of unexplained origin), or referred for colonoscopy owing to a positive fecal immunochemical test (FIT) or guaiac fecal occult blood test (gFOBT) result.
Who cannot join
- familial adenomatous polyposis and hereditary non-polyposis CRC syndrome
- personal history of serrated polyposis syndrome
- personal history of CRC
- history of inflammatory bowel disease
- previous colonic resection
- overt gastrointestinal bleeding
Show all 14Show fewer
- emergency colonoscopy or inpatients
- planned EMR or ESD of large polyps
- colon stricture or obstruction
- contraindications to colonoscopy (eg, acute diverticulitis or toxic megacolon)
- antithrombotic therapy precluding complete polyp resection
- American Society of Anesthesiology classification of physical status >3
- pregnant women or women planning pregnancy
- refusal to provide a written informed consent
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 4 countries
Canada1 site, 1 recruiting
- Not yet recruiting
University of Montreal Medical Center (CHUM)
Montreal, Quebec, H2X 0A9
Daniel von Renteln, MD, 5148908000 ext. 30912, daniel.von.renteln.med@ssss.gouv.qc.ca
Roupen Djinbachian, MD
Italy1 site, 1 recruiting
- Not yet recruiting
Ospedale Valduce
Como, 22100
Franco Radaelli, MD, +39 031 324171, francoradaelli01@gmail.com
Franco Radaelli, MD
Taiwan1 site, 1 recruiting
- Recruiting
Evergreen General Hospital
Taoyuan, 320
Chi-Liang Cheng, MD, 0919768058, chiliang.cheng@gmail.com
Yen-Lin Kuo, MD
Thailand1 site, 1 recruiting
- Not yet recruiting
King Chulalongkorn Memorial Hospital
Bangkok, 10330
Rungsun Rerknimitr, MD, +66 81 902 6633, ERCP@live.com
Piyapoom Pakvisal, MD, Msc
About this study
Official title: A Multicenter Prospective Randomized Controlled Trial of Linked-Color Imaging for Detection of Clinically Significant Serrated Lesions in Computer-Aided Water Exchange Colonoscopy
The goal of this clinical trial is to compare the detection rate of clinically significant serrated lesions (CSSL) in participants undergoing water exchange (WE) colonoscopy with artificial intelligence (AI)-based computer-aided detection (CADe) for screening, surveillance, diagnosis for symptoms, or referred owing to a positive fecal immunochemical test (FIT) or guaiac fecal occult blood test (gFOBT) result. There will be two arms in this study: WE with AI-assisted CADe (WEAID) control and WEAID plus linked-color imaging (LCI). The main question it aims to answer is whether the addition of LCI into WEAID colonoscopy increases CSSL detection rate. Both groups use water instead of air to insert the colonoscope into the cecum. The control method uses CADe to help detect colonic lesions. The study method uses a combination of CADe and LCI to detect lesions. Researchers will compare CSSL detection rate to see if the addition of LCI increases the detection of CSSL during CADe-assisted WE colonoscopy.
Read the detailed description
This will be a multicenter, unblinded investigators, prospective randomized controlled trial (RCT). Randomization (1:1 to WEAID alone and WEAID plus LCI) will be based on computer generated random numbers placed inside opaque sealed envelopes. The envelope (in pre-arranged order) will be opened to reveal the code when the colonoscopist is ready to insert the endoscope to begin the examination. This will be a comparison of two different methods with two arms (WEAID, WEAID-LCI) to see which one is better at detecting CSSL.
Patient recruitment will be conducted at 4 hospitals: University of Montreal Medical Center (CHUM), Quebec, Canada; Evergreen General Hospital, Taoyuan, Taiwan; King Chulalongkorn Memorial Hospital, Bangkok, Thailand; and Ospedale Valduce, Como, Italy. The study period is expected to be 2 years (from August 2025 to July 2027).
Patients aged 40-80 y/o at average risk of colorectal cancer who are willing to participate will sign an informed consent before starting the colonoscopy procedure. Separate parallel randomization will be set up at each site, stratified by investigator and indication of colonoscopy (screening, surveillance, diagnostic, or positive FIT or gFOBT result). Mode of sedation will include no sedation, on-demand sedation, conscious sedation or full sedation with propofol. Randomization will be carried out by computer-generated sequences.
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. The same endoscopist performs the insertion and withdrawal of colonoscopy. The colonoscope will be inserted with WE method, instead of air insufflation. WE involves simultaneous infusion of distilled water to facilitate luminal expansion and suction of unclean water.
Control Method: One arm of the study will include CADe as the control method. The CADe system 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.
Study method: The other arm entails the addition of a commercially available image-enhanced LCI technique (Fujifilm) to the CADe system. LCI will be activated during the withdrawal phase to enhance visualization of the lesions.
- Being tested
- Water exchange with AI-assisted detection, Water exchange with AI-assisted detection and LCI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water exchange with AI-assisted detectionDevice
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.
Water exchange with AI-assisted detection and LCIDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Water exchange with AI-assisted detection | Active comparator | 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. Receives: Device: Water exchange with AI-assisted detection |
| Water exchange with AI-assisted detection and LCI | Experimental | 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. Receives: Device: Water exchange with AI-assisted detection and LCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically significant serrated lesion (CSSL) detection rate
Percentage of patients who have 1 or more histologically confirmed CSSLs, including sessile serrated lesions, traditional serrated adenomas, hyperplastic polyps measuring ≥10 mm anywhere in the colon, or hyperplastic polyps measuring 6-9 mm in the proximal colon (cecum to splenic flexure).
Measured: One week (after the colonoscopy procedure, when pathology report is released)
Secondary outcomes (5)
Sessile serrated lesion (SSL) detection rate
Percentage of patients who have 1 or more histologically confirmed SSL with or without dysplasia.
Measured: One week (after the colonoscopy procedure, when pathology report is released)
Proximal serrated lesion detection rate
Percentage of patients who have 1 or more histologically confirmed proximal serrated lesions, including sessile serrated lesion, translational serrated adenoma, and hyperplastic polyp. The proximal colon includes the cecum, ascending colon, hepatic flexure, transverse colon, and splenic flexure.
Measured: One week (after the colonoscopy procedure, when pathology report is released)
High-risk neoplasm detection rate
Percentage of patients who have 1 or more histologically confirmed advanced adenoma, or ≥5 low-risk adenomas (defined as 1 to 2 tubular adenomas <10 mm with low-grade dysplasia), or any serrated lesions ≥10 mm or with dysplasia. Advanced adenomas are defined as those adenomas meeting at least one of the following criteria: (1) size ≥10 mm, (2) presence of 25% villous components, and (3) high-grade dysplasia.
Measured: One week (after the colonoscopy procedure, when pathology report is released)
Adenoma detection rate
Percentage of patients who have 1 or more histologically confirmed conventional adenomas.
Measured: One week (after the colonoscopy procedure, when pathology report is released)
Adenoma per colonoscopy
Total number of histologically confirmed adenomas divided by the total number of colonoscopies.
Measured: One week (after the colonoscopy procedure, when pathology report is released)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start17 Nov 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sessile Colonic PolypStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,090 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Evergreen General Hospital, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- Centre hospitalier de l'Université de Montréal (CHUM), King Chulalongkorn Memorial Hospital, Valduce Hospital
- Responsible party
- Sponsor
- Investigators
- Chi-Liang Cheng, MD, Study chair, Evergreen General Hospital, TaoyuanRungsun Rerknimitr, MD, Principal investigator, Center of Excellence for Innovation and Endoscopy in Gastrointestinal Oncology, King Chulalongkorn Memorial HospitalDaniel von Renteln, MD, Principal investigator, Research, Gastroenterology Division, University of Montreal Medical Center (CHUM)Franco Radaelli, MD, Principal investigator, Gastroenterology Unit, Ospedale Valduce
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127471
- Sponsor's protocol ID
- WEAID with LCI
- Status last verified
- Sep 2026
- First submitted
- 11 Aug 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anderson JC, Hisey W, Mackenzie TA, Robinson CM, Srivastava A, Meester RGS, Butterly LF. Clinically significant serrated polyp detection rates and risk for postcolonoscopy colorectal cancer: data from the New Hampshire Colonoscopy Registry. Gastrointest Endosc. 2022 Aug;96(2):310-317. doi: 10.1016/j.gie.2022.03.001. Epub 2022 Mar 8.
PubMed 35276209Anderson JC, Rex DK, Mackenzie TA, Hisey W, Robinson CM, Butterly LF. Higher Serrated Polyp Detection Rates Are Associated With Lower Risk of Postcolonoscopy Colorectal Cancer: Data From the New Hampshire Colonoscopy Registry. Am J Gastroenterol. 2023 Nov 1;118(11):1927-1930. doi: 10.14309/ajg.0000000000002403. Epub 2023 Jul 7.
PubMed 37417792
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Randomized Controlled Trial of Linked-Color Imaging for Detection of Clinically Significant Serrated Lesions in Computer-Aided Water Exchange Colonoscopy
- ClinicalTrials.gov ID
- NCT07127471
- Acronym / sponsor ID
- WEAID with LCI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,090 participants (estimated)
- Lead sponsor
- Evergreen General Hospital, TaiwanUniversity, hospital or other
- Collaborators
- Centre hospitalier de l'Université de Montréal (CHUM), King Chulalongkorn Memorial Hospital, Valduce Hospital
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare the detection rate of clinically significant serrated lesions (CSSL) in participants undergoing water exchange (WE) colonoscopy with artificial intelligence (AI)-based computer-aided detection (CADe) for screening, surveillance, diagnosis for symptoms, or referred owing to a positive fecal immunochemical test (FIT) or guaiac fecal occult blood test (gFOBT) result. There will be two arms in this study: WE with AI-assisted CADe (WEAID) control and WEAID plus linked-color imaging (LCI). The main question it aims to answer is whether the addition of LCI into WEAID colonoscopy increases CSSL detection rate. Both groups use water instead of air to insert the colonoscope into the cecum. The control method uses CADe to help detect colonic lesions. The study method uses a combination of CADe and LCI to detect lesions. Researchers will compare CSSL detection rate to see if the addition of LCI increases the detection of CSSL during CADe-assisted WE colonoscopy.
Detailed description
This will be a multicenter, unblinded investigators, prospective randomized controlled trial (RCT). Randomization (1:1 to WEAID alone and WEAID plus LCI) will be based on computer generated random numbers placed inside opaque sealed envelopes. The envelope (in pre-arranged order) will be opened to reveal the code when the colonoscopist is ready to insert the endoscope to begin the examination. This will be a comparison of two different methods with two arms (WEAID, WEAID-LCI) to see which one is better at detecting CSSL.
Patient recruitment will be conducted at 4 hospitals: University of Montreal Medical Center (CHUM), Quebec, Canada; Evergreen General Hospital, Taoyuan, Taiwan; King Chulalongkorn Memorial Hospital, Bangkok, Thailand; and Ospedale Valduce, Como, Italy. The study period is expected to be 2 years (from August 2025 to July 2027).
Patients aged 40-80 y/o at average risk of colorectal cancer who are willing to participate will sign an informed consent before starting the colonoscopy procedure. Separate parallel randomization will be set up at each site, stratified by investigator and indication of colonoscopy (screening, surveillance, diagnostic, or positive FIT or gFOBT result). Mode of sedation will include no sedation, on-demand sedation, conscious sedation or full sedation with propofol. Randomization will be carried out by computer-generated sequences.
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. The same endoscopist performs the insertion and withdrawal of colonoscopy. The colonoscope will be inserted with WE method, instead of air insufflation. WE involves simultaneous infusion of distilled water to facilitate luminal expansion and suction of unclean water.
Control Method: One arm of the study will include CADe as the control method. The CADe system 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.
Study method: The other arm entails the addition of a commercially available image-enhanced LCI technique (Fujifilm) to the CADe system. LCI will be activated during the withdrawal phase to enhance visualization of the lesions.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Water exchange with AI-assisted detection | Active comparator | Device: Water exchange with AI-assisted detectionThe 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. |
| Water exchange with AI-assisted detection and LCI | Experimental | Device: Water exchange with AI-assisted detection and LCIThe 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female patients aged 40-80 years scheduled for average-risk screening colonoscopy, post-polypectomy surveillance, diagnosis for gastrointestinal symptoms (including unexplained iron deficiency anemia and clinically significant diarrhea of unexplained origin), or referred for colonoscopy owing to a positive fecal immunochemical test (FIT) or guaiac fecal occult blood test (gFOBT) result.
Key exclusion criteria (14 listed)
- familial adenomatous polyposis and hereditary non-polyposis CRC syndrome
- personal history of serrated polyposis syndrome
- personal history of CRC
- history of inflammatory bowel disease
- previous colonic resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water exchange with AI-assisted detectionThe 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. | Device | Water exchange with AI-assisted detection |
| Water exchange with AI-assisted detection and LCIThe 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. | Device | Water exchange with AI-assisted detection and LCI |
Primary outcome
Clinically significant serrated lesion (CSSL) detection rate
Time frame: One week (after the colonoscopy procedure, when pathology report is released)
Percentage of patients who have 1 or more histologically confirmed CSSLs, including sessile serrated lesions, traditional serrated adenomas, hyperplastic polyps measuring ≥10 mm anywhere in the colon, or hyperplastic polyps measuring 6-9 mm in the proximal colon (cecum to splenic flexure).
5 secondary outcomes
Sessile serrated lesion (SSL) detection rate
Time frame: One week (after the colonoscopy procedure, when pathology report is released)
Proximal serrated lesion detection rate
Time frame: One week (after the colonoscopy procedure, when pathology report is released)
High-risk neoplasm detection rate
Time frame: One week (after the colonoscopy procedure, when pathology report is released)
Adenoma detection rate
Time frame: One week (after the colonoscopy procedure, when pathology report is released)
Adenoma per colonoscopy
Time frame: One week (after the colonoscopy procedure, when pathology report is released)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Background: PubMed 35276209Anderson JC, Hisey W, Mackenzie TA, Robinson CM, Srivastava A, Meester RGS, Butterly LF. Clinically significant serrated polyp detection rates and risk for postcolonoscopy colorectal cancer: data from the New Hampshire Colonoscopy Registry. Gastrointest Endosc. 2022 Aug;96(2):310-317. doi: 10.1016/j.gie.2022.03.001. Epub 2022 Mar 8.
- Background: PubMed 37417792Anderson JC, Rex DK, Mackenzie TA, Hisey W, Robinson CM, Butterly LF. Higher Serrated Polyp Detection Rates Are Associated With Lower Risk of Postcolonoscopy Colorectal Cancer: Data From the New Hampshire Colonoscopy Registry. Am J Gastroenterol. 2023 Nov 1;118(11):1927-1930. doi: 10.14309/ajg.0000000000002403. Epub 2023 Jul 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chi-Liang Cheng, MD study chair
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)
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water exchange with AI-assisted detection and Water exchange with AI-assisted detection and LCI in people with Sessile Colonic Polyp and Serrated Lesion, run by Evergreen General Hospital, Taiwan at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada, Italy, Taiwan, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chi-Liang Cheng, MD (+886 919 768058, chiliang.cheng@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically significant serrated lesion (CSSL) detection rate (time frame: One week (after the colonoscopy procedure, when pathology report is released)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07127471, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.