Colon PolypNCT06345105
Prospective Evalulation of Artificial Intelligence-assisted Monitoring of Effective Withdrawal Time Versus Standard Withdrawal Time on Adenoma Detected Per Colonoscopy
An observational study of Colon Polyp and Colon Adenoma, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The goal of this observational study is to assess the correlation between the artificial intelligence (AI) derived effective withdrawal time (EWT) during colonoscopy and endoscopists' adenoma per colonoscopy (APC), polyp per colonoscopy(PPC), adenoma detection rate (ADR), polyp detection rate (PDR) and during… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colon Polyp, Colon Adenoma, Artificial Intelligence
- What is being tested?
- Endoscreener QC
- Type of treatment
- Medical device
- How many people
- 198 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Nov 2023to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patient will be recruited in Queen Mary Hospital, Hong Kong, China
Who may be able to join
- All adult patients, aged 40 or above, undergoing outpatient colonoscopy will be recruited
Who cannot join
- history of inflammatory bowel disease
- history of colorectal cancer
- previous bowel resection (apart from appendectomy)
- Peutz-Jeghers syndrome, familial adenomatous polyposis or other polyposis syndromes
- bleeding tendency or severe comorbid illnesses for which polypectomy is considered unsafe.
- Cecum could not be intubated for various reasons
- Poor bowel preparation with Boston Bowel Preparation Scale (BBPS) < 6
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to assess the correlation between the artificial intelligence (AI) derived effective withdrawal time (EWT) during colonoscopy and endoscopists' adenoma per colonoscopy (APC), polyp per colonoscopy(PPC), adenoma detection rate (ADR), polyp detection rate (PDR) and during colonoscopy for each endoscopists. The association between the AI derived EWT with all colonoscopy outcomes during the prospective colonoscopy series would also be determined. The colonoscopy video of participants will be monitored by the AI. The result will be compared with standard withdrawal time (SWT).
Read the detailed description
This is a prospective colonoscopy trial using artificial intelligence (AI) real time effective mucosal examination monitor system (EndoScreener QC, Wision A.I. Shanghai \& Chengdu). Low residue diet will be taken by all patients two days before the scheduled colonoscopy. Oral polyethylene glycol lavage solution is used for bowel preparation as in usual hospital practice. All examination will be performed with high-definition endoscopes (EVIS-EXERA 290 video system, Olympus Optical, Tokyo, Japan) under white light by experienced endoscopists. In all colonoscopy examination, colonoscope will be first advanced to the cecum as confirmed by identification of the appendiceal orifice and ileocecal valve or by intubation of the ileum. After cecal intubation is performed, the colonoscopy is slowly withdrawn. All detected polyps will be removed during the withdrawal only. The size (measured with biopsy forceps), location and morphology of each polyp will be recorded by an independent observer. The withdrawal time (minus the polypectomy site) will be measured by a stopwatch and with a minimum of 6 minutes. The bowel preparation quality will be graded according to the Boston Bowel Preparation Scale. The AI derived (AI) real time effective mucosal examination monitor system (EndoScreen QC) will be initiated during scope withdrawal, starting from cecum to anus. The polypectomy or biopsy time will be removed as determination of standard withdrawal time. All endoscopists will be blinded to the results of AI real time monitoring of EWT. All polyp specimens removed will be clearly labelled and send for histological examination. All resected and biopsy specimens are fixed in 10% buffered formalin solution, and examined histologically by hematoxylin and eosin staining. The histopathological diagnosis is determined by experienced pathologists, who are blinded to the assigned endoscopic system, according to the World Health Organization (WHO) criteria. Advanced adenomas are defined as adenoma ≥10 mm in diameter or with villous histology in 25% or high-grade dysplasia (HGD), or carcinoma.The primary outcome of this study is to correlate the adenoma detection rates of the endoscopists with EWT.
- Conditions
- Colon Polyp, Colon Adenoma, Artificial Intelligence
- Being tested
- Endoscreener QC
- Keywords
- Colon Polyp, Artificial Intelligence, Withdrawal time
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscreener QCDevice
Artificial intelligence monitoring of effective withdrawal time
| Study group | Role | What they receive |
|---|---|---|
| AI group | AI monitoring of effective withdrawal time Receives: Device: Endoscreener QC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma per colonoscopy of the endoscopists
Adenoma per colonoscopy of the endoscopists
Measured: During the colonoscopy
Secondary outcomes (5)
Adenoma detection rate of the endoscopists
Adenoma detection rate of the endoscopists
Measured: During that colonoscopy
Polyp detection rate of the endoscopists
Polyp detection rate of the endoscopists
Measured: During that colonoscopy
Polyp per colonoscopy of the endoscopists
Polyp per colonoscopy of the endoscopists
Measured: During colonoscopy
Serrated Lesion per Colonoscopy of the endoscopist
Serrated Lesion per Colonoscopy of the endoscopist
Measured: During the colonoscopy
Serrated Lesion Detection Rate of the endoscopist
Serrated Lesion Detection Rate of the endoscopist
Measured: During colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start1 Nov 2023
- Primary completion30 Sep 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon PolypStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Ka-Luen Lui, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345105
- Sponsor's protocol ID
- AIeffectiveV4
- Status last verified
- Nov 2023
- First submitted
- 22 Mar 2024
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evalulation of Artificial Intelligence-assisted Monitoring of Effective Withdrawal Time Versus Standard Withdrawal Time on Adenoma Detected Per Colonoscopy
- ClinicalTrials.gov ID
- NCT06345105
- Acronym / sponsor ID
- AIeffectiveV4
- Conditions
- Colon Polyp, Colon Adenoma, Artificial Intelligence
- Keywords
- Colon Polyp, Artificial Intelligence, Withdrawal time
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 3 Apr 2024 (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 observational study is to assess the correlation between the artificial intelligence (AI) derived effective withdrawal time (EWT) during colonoscopy and endoscopists' adenoma per colonoscopy (APC), polyp per colonoscopy(PPC), adenoma detection rate (ADR), polyp detection rate (PDR) and during colonoscopy for each endoscopists. The association between the AI derived EWT with all colonoscopy outcomes during the prospective colonoscopy series would also be determined. The colonoscopy video of participants will be monitored by the AI. The result will be compared with standard withdrawal time (SWT).
Detailed description
This is a prospective colonoscopy trial using artificial intelligence (AI) real time effective mucosal examination monitor system (EndoScreener QC, Wision A.I. Shanghai \& Chengdu). Low residue diet will be taken by all patients two days before the scheduled colonoscopy. Oral polyethylene glycol lavage solution is used for bowel preparation as in usual hospital practice. All examination will be performed with high-definition endoscopes (EVIS-EXERA 290 video system, Olympus Optical, Tokyo, Japan) under white light by experienced endoscopists. In all colonoscopy examination, colonoscope will be first advanced to the cecum as confirmed by identification of the appendiceal orifice and ileocecal valve or by intubation of the ileum. After cecal intubation is performed, the colonoscopy is slowly withdrawn. All detected polyps will be removed during the withdrawal only. The size (measured with biopsy forceps), location and morphology of each polyp will be recorded by an independent observer. The withdrawal time (minus the polypectomy site) will be measured by a stopwatch and with a minimum of 6 minutes. The bowel preparation quality will be graded according to the Boston Bowel Preparation Scale. The AI derived (AI) real time effective mucosal examination monitor system (EndoScreen QC) will be initiated during scope withdrawal, starting from cecum to anus. The polypectomy or biopsy time will be removed as determination of standard withdrawal time. All endoscopists will be blinded to the results of AI real time monitoring of EWT. All polyp specimens removed will be clearly labelled and send for histological examination. All resected and biopsy specimens are fixed in 10% buffered formalin solution, and examined histologically by hematoxylin and eosin staining. The histopathological diagnosis is determined by experienced pathologists, who are blinded to the assigned endoscopic system, according to the World Health Organization (WHO) criteria. Advanced adenomas are defined as adenoma ≥10 mm in diameter or with villous histology in 25% or high-grade dysplasia (HGD), or carcinoma.The primary outcome of this study is to correlate the adenoma detection rates of the endoscopists with EWT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AI group | – | Device: Endoscreener QCAI monitoring of effective withdrawal time |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patient will be recruited in Queen Mary Hospital, Hong Kong, China
Key inclusion criteria (1 listed)
- All adult patients, aged 40 or above, undergoing outpatient colonoscopy will be recruited
Key exclusion criteria (7 listed)
- history of inflammatory bowel disease
- history of colorectal cancer
- previous bowel resection (apart from appendectomy)
- Peutz-Jeghers syndrome, familial adenomatous polyposis or other polyposis syndromes
- bleeding tendency or severe comorbid illnesses for which polypectomy is considered unsafe.
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 |
|---|---|---|
| Endoscreener QCArtificial intelligence monitoring of effective withdrawal time | Device | AI group |
Primary outcome
Adenoma per colonoscopy of the endoscopists
Time frame: During the colonoscopy
Adenoma per colonoscopy of the endoscopists
5 secondary outcomes
Adenoma detection rate of the endoscopists
Time frame: During that colonoscopy
Polyp detection rate of the endoscopists
Time frame: During that colonoscopy
Polyp per colonoscopy of the endoscopists
Time frame: During colonoscopy
Serrated Lesion per Colonoscopy of the endoscopist
Time frame: During the colonoscopy
Serrated Lesion Detection Rate of the endoscopist
Time frame: During colonoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- 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. This study is not recruiting at the moment.
Thomas Ka-Luen Lui principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Polyp and Colon Adenoma, run by The University of Hong Kong at 1 site in Hong Kong.
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 7 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: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma per colonoscopy of the endoscopists (time frame: During the colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2025.