NCT07650344

Brief Summary

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
628

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started May 2026

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
May 2026May 2027

Study Start

First participant enrolled

May 21, 2026

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 16, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2027

Last Updated

June 16, 2026

Status Verified

June 1, 2026

Enrollment Period

12 months

First QC Date

June 10, 2026

Last Update Submit

June 10, 2026

Conditions

Sessile Serrated LesionCADe

Keywords

sessile serrated lesionAICADe

Outcome Measures

Primary Outcomes (1)

  • SSL per colonoscopy (SPC) using White Light Endoscopy alone vs enhancement by CADe system.

    up to a year

Secondary Outcomes (1)

  • 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

    up to a year

Study Arms (2)

AI-assisted colonoscopy

ACTIVE COMPARATOR
Device: usage of CADe system

Conventional Colonoscopy

NO INTERVENTION

Conventional Colonoscopy using white light

Interventions

usage of CADe systemDEVICE

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).

AI-assisted colonoscopy

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Tan Tock Seng Hospital

Singapore, 308433, Singapore

RECRUITING

Changi General Hospital

Singapore, Singapore

NOT YET RECRUITING

National University of Singapore

Singapore, Singapore

RECRUITING

Related Publications (1)

  • 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)

    BACKGROUND

Study Officials

  • Joseph JY Sung, PHD

    Nanyang Technological University

    STUDY CHAIR

Central Study Contacts

Weida Chew, Masters

CONTACT

63577897wei.da.chew@nhghealth.com.sg

Aei Aei Zaw

CONTACT

63573116aei.aei.zaw@nhghealth.com.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Pathologists
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: The colonoscopy will be performed by credentialed endoscopists and it will be performed under conscious sedation with intravenous midazolam and/or fentanyl. Anti-peristaltic agents such as intravenous glucagon or buscopan may be used at the discretion of the Endoscopist but however mucosal exposure devices were not allowed. Electronic image enhancing function was not allowed for polyp detection but could be used for polyp characterization at the discretion of the endoscopists. Bowel preparation quality will be rated by the Boston Bowel Preparation Scale (BBPS) with adequate bowel preparation being defined as BBPS score ≥6 and any segmental BBPS score ≥2. Evaluation and resection of detected colonic polyps will be performed as per routine clinical practices. Participants will be randomized in a 1:1 ratio to either: * Intervention Arm: CADe-assisted colonoscopy * Control Arm: Standard white-light endoscopy (WLE) using conventional colonoscopy
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant

Study Record Dates

First Submitted

June 10, 2026

First Posted

June 16, 2026

Study Start

May 21, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 3, 2027

Last Updated

June 16, 2026

Record last verified: 2026-06

Locations

SG(3)