Sessile Serrated LesionAI-SSLDNCT07650344
USAGE OF ARITIFICIAL INTELLIGENCE IN AIDING WITH COLONIC SESSILE SERRATED LESIONS DETECTION AND DIAGNOSIS (AI-SSL)
A study testing usage of CADe system in people with Sessile Serrated Lesion and CADe, run by National Healthcare Group, Singapore at 3 sites in Singapore.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sessile Serrated Lesion, CADe
- What is being tested?
- usage of CADe system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 628 participants
- Where
- 3 sitesSingapore
- Study dates
- 21 May 2026to 3 May 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
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore3 sites, 3 recruiting
- Recruiting
Tan Tock Seng Hospital
Singapore, 308433
Weida Chew, Masters, 6563577897, wei.da.chew@nhghealth.com.sg
Aei Aei Zaw, 6563573116, aei.aei.zaw@nhghealth.com.sg
- Not yet recruiting
Changi General Hospital
Singapore
Clinical Research Coordinator, 6569365716, ctru@cgh.com.sg
Research Office Manager, ctru@cgh.com.sg
- Recruiting
National University of Singapore
Singapore
Xiaodan Cai, 6567725073, Xiaodan_Cai@nuhs.edu.sg
Jonathan Wei Jie Lee, jonathan_wj_lee@nuhs.edu.sg
About this study
Official title: 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).
Read the 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%.
- Conditions
- Sessile Serrated Lesion, CADe
- Being tested
- usage of CADe system
- Keywords
- sessile serrated lesion, AI, CADe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| AI-assisted colonoscopy | Active comparator | Not described Receives: Device: usage of CADe system |
| Conventional Colonoscopy | No intervention | Conventional Colonoscopy using white light |
What is being measured
The primary outcome is the main question the study is designed to answer.
SSL per colonoscopy (SPC) using White Light Endoscopy alone vs enhancement by CADe system.
Measured: 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
Measured: up to a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start21 May 2026
- Primary completionMay 2027 (estimated)
- Study completion3 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sessile Serrated LesionStudies 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
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 628 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Healthcare Group, Singapore
- Sponsor type
- Other government
- Collaborators
- Changi General Hospital, National University Health System, Singapore
- Responsible party
- Principal investigator, Chew Wei Da, National Healthcare Group, Singapore
- Investigators
- Joseph JY Sung, PHD, Study chair, Nanyang Technological University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07650344
- Sponsor's protocol ID
- 2025-1940
- Acronym
- AI-SSLD
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- USAGE OF ARITIFICIAL INTELLIGENCE IN AIDING WITH COLONIC SESSILE SERRATED LESIONS DETECTION AND DIAGNOSIS (AI-SSLD)
- ClinicalTrials.gov ID
- NCT07650344
- Acronym / sponsor ID
- AI-SSLD / 2025-1940
- Conditions
- Sessile Serrated Lesion, CADe
- Keywords
- sessile serrated lesion, AI, CADe
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 628 participants (estimated)
- Lead sponsor
- National Healthcare Group, SingaporeOther government
- Collaborators
- Changi General Hospital, National University Health System, Singapore
- Study start
- 21 May 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- 3 May 2027 (estimated)
- First posted
- 16 Jun 2026 (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 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).
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| AI-assisted colonoscopy | Active comparator | Device: usage of CADe system |
| Conventional Colonoscopy | No intervention | –Conventional Colonoscopy using white light |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| usage of CADe systemA real-time Computer Aided Detection (CADe) system can help improve the detection of SSL versus a conventional colonoscopy (CC) using white light examination(WLE). | Device | AI-assisted colonoscopy |
Primary outcome
SSL per colonoscopy (SPC) using White Light Endoscopy alone vs enhancement by CADe system.
Time frame: up to a year
1 secondary outcome
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
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 16 Jun 2026.
- Background1.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)
- Individual participant dataSharing planned: Undecided
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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.
Joseph JY Sung, PHD study chair
Nanyang Technological University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing usage of CADe system in people with Sessile Serrated Lesion and CADe, run by National Healthcare Group, Singapore at 3 sites in Singapore.
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 1 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 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Singapore. 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 Weida Chew, Masters (63577897, wei.da.chew@nhghealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SSL per colonoscopy (SPC) using White Light Endoscopy alone vs enhancement by CADe system. (time frame: up to a year). 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 NCT07650344, which also lists 1 linked publication.
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 16 Jun 2026.