USAGE OF ARITIFICIAL INTELLIGENCE IN AIDING WITH COLONIC SESSILE SERRATED LESIONS DETECTION AND DIAGNOSIS (AI-SSL) (AI-SSLD)

June 10, 2026 updated by: Chew Wei Da, National Healthcare Group, Singapore

USAGE OF ARITIFICIAL INTELLIGENCE IN AIDING WITH COLONIC SESSILE SERRATED LESIONS DETECTION AND DIAGNOSIS (AI-SSLD)

The aim of this study is to is to evaluate if a real-time Computer Aided Detection (CADe) system can help improve the detection of SSL(sessile serrated lesions) versus a conventional colonoscopy (CC) using white light examination(WLE).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The serrated pathway is believed to account for 30% of all colorectal cancers (CRC). However, as detection rates vary widely among endoscopists and pathologists, there is uncertainty about the prevalence of these lesions [1]. Prevalence varies with study location, diagnostic criteria and examination quality. Relatively little is known about the epidemiology of these lesions (prevalence, location, family history) and risk of malignant transformation (timing, associated factors). A systematic review reported prevalence of sessile serrated lesions (SSL) was 3.9% in Europe and 5.1% in the US.

In Asia, only few reports on Sessile Serrated lesion (SSL) have been published. In a CRC screening study from Hong Kong recruiting 6,011 subjects, 486 (8.1%) subjects were reported to have HPs and only 85 (1.4%) SSL [2]. A study from Japan recruiting 5,218 asymptomatic subjects for CRC screening reported detection rates of serrated lesions of 23.3% and of right-sided serrated lesions of 7.6% respectively [3]. In this study, high-quality video endoscopes with narrow-band imaging (NBI) and magnification were used with 0.4% indigo carmine dye to enhance the detection of flat lesions. On the other hand, In Australia, the prevalence of SSL in Chinese (2%) was lower when compared with Caucasian (7%) subjects [4]. Studies have shown that SSLs are associated with CRC, especially those on the right colon and in the elderly age group, and hence should be detected and remove.[5] In addition to the potential for malignant transformation of SSL, individuals with these lesions are reportedly at higher risk of development of synchronous and metachronous CRC and advanced colorectal neoplasia (ACN) at other sites. [6-8]

Training for endoscopists and pathologists to identify SSL will likely increase detection rates, improve the prevalence of estimates of these lesions and hence reduce the incidence of interval post-colonoscopy colorectal cancer [9] The high variability between studies on the SSL prevalence, is at least partly explained by varying detection rates of serrated lesions between endoscopists, as this rate appears highly operator dependent.

Currently, CADe has been shown to improve adenoma detection rate by around 30%.[10] With the existing algorithm, SSL detection has not been improved irrespective of endoscopist experience, system type or healthcare setting. [11] This is because focus has always been put on adenomatous polyps. SSLs are sessile or flat lesions measuring average size 5-7mm and can be easily missed during conventional colonoscopy as they are usually normal to pale in color They may exhibit distinct endoscopic features such as overlying mucus cap, cloud-like surface, ring of debris or stool around the lesion and obscured mucosal vasculature During narrow-band imaging endoscopy, they have a cloud-like appearance, irregular shape, and dark spots inside the crypts. Better bowel preparation, longer withdrawal time, and careful examination of the right colon (with repeated anterograde examination or retroflexion in the caecum) improved detection of SSL [12]. Electronic chromoendoscopy such as NBI may marginally improve the detection of SSL but is currently not recommended as mandatory practice, because clear scientific evidence is lacking.

Usage of CADe system has been shown in several studies to improve polyp detection rate even amongst junior endoscopists but however most of the CADE system is trained to focus on adenomatous polyp. This AI algorithm has been trained to detect SSL. If proven to be effective in a real-world setting, this will improve outcomes of patients undergoing colonoscopies and reduce the risk of interval colon cancers post colonoscopies.

We hypothesise that usage of CADe system can improve SSL detection significantly from 2% with conventional White Light endoscopy to 6.5%.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
628

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Singapore
      • Singapore, Singapore, 308433
      • Singapore, Singapore
      • Singapore, Singapore
        • Not yet recruiting
        • Changi General Hospital
        • Contact:
          • Clinical Research Coordinator
          • Phone Number: 6569365716
          • Email: ctru@cgh.com.sg
        • Contact:
        • Principal Investigator:
          • Tiing Leong Ang, Phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Adult (40 - 80 years) Undergoing colonoscopy for screening, surveillance, or diagnostic indications. Complete colonoscopy with satisfactory Boston Bowel Prep Scale of 6 or higher. Provide informed consent to participate in the study

Exclusion Criteria:

Personal or family history of colorectal cancer Personal or family history of colonic polyposis syndromes Personal or family history of inflammatory bowel disease Prior colorectal surgery Contraindications to colonoscopy (intestinal obstruction, medical conditions that will make the risk of colonoscopy too high) Contraindications to polypectomy (ongoing anticoagulation / double antiplatelet therapy that cannot be stopped for the colonoscopy) Inability to give consent Incomplete colonoscopy/ Unable to retrieve specimen for pathology Poor bowel preparation (Boston Bowel Prep Scale <6) Pregnant Women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: AI-assisted colonoscopy
Device: usage of CADe system
A real-time Computer Aided Detection (CADe) system can help improve the detection of SSL versus a conventional colonoscopy (CC) using white light examination(WLE).
No Intervention: Conventional Colonoscopy
Conventional Colonoscopy using white light

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
SSL per colonoscopy (SPC) using White Light Endoscopy alone vs enhancement by CADe system.
Time Frame: up to a year
up to a year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
1) Adenoma per colonoscopy (APC) using White Light Endoscopy alone vs enhancement by CADe system. 2) Polyp per colonoscopy (PPC) using White Light Endoscopy alone vs enhancement by CADe system. 3) Difference in the SPC, APC, PPC for each proceduralist
Time Frame: up to a year
up to a year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Healthcare Group, Singapore

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Changi General Hospital
National University Health System, Singapore

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Joseph JY Sung, PHD, Nanyang Technological University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 1.Meester RGS, van Herk M, Lansdorp-Vogelaar I, et al. Prevalence and clinical features of sessile serrated polyps: a systematic review. Gastroenterology 2020;159:105-118.e25 2.Lui, R. N. et al. Prevalence and risk factors for sessile serrated lesions in an average risk colorectal cancer screening population. J. Gastroenterol. Hepatol. 36, 1656-1662 (2021) 3.Sekiguchi M, Matsuda T Prevalence of serrated lesions, risk factors, and their association with synchronous advanced colorectal neoplasia in asymptomatic screened individuals. J Gastroenterol Hepatol. 2020 Nov;35(11):1938-1944 doi: 10.1111/jgh.15116. Epub 2020 Jun 10 4.Sung JJY, Chiu HM Third Asia-Pacific consensus recommendations on colorectal cancer screening and postpolypectomy surveillance. Gut. 2022 Nov;71(11):2152-2166. doi: 10.1136/gutjnl-2022-327377. Epub 2022 Aug 24 5.Song M, Emilsson L, Bozorg SR, et al. Risk of colorectal cancer incidence and mortality after polypectomy: a Swedish recordlinkage study. Lancet Gastroenterol Hepatol 2020;5:537-547. 6.Gao Q, Tsoi KK, Hirai HW, et al. Serrated polyps and the risk of synchronous colorectal advanced neoplasia: a systematic review and meta-analysis. Am J Gastroenterol. 2015; 110: 501-9. 7.He X, Hang D, Wu K, et al. Long-term Risk of Colorectal Cancer After Removal of Conventional Adenomas and Serrated Polyps. Gastroenterology. 2020; 158: 852-61. 8.Ng SC, Sung JJ. Association between serrated polyps and the risk of synchronous advanced colorectal neoplasia in average-risk individuals. Aliment Pharmacol Ther. 2015 Jan;41(1):108-15. doi: 10.1111/apt.13003. Epub 2014 Oct 22. PMID: 25339583. 9.David E F W M van Toledo et al, Serrated polyp detection and risk of interval post-colonoscopy colorectal cancer: a population-based study, The Lancet Gastroenterology & Hepatology, Volume 7, Issue 8, 2022, Pages 747-754 10.Repici A, Hassan C. Efficacy of Real-Time Computer-Aided Detection of Colorectal Neoplasia in a Randomized Trial. Gastroenterology. 2020 Aug;159(2)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 21, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 3, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-1940

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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