Colonic PolypNCT06063720
Effective Withdrawal Time and Adenoma Detection Rate
An observational study of Colonic Polyp and Colon Adenoma, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study prospectively evaluated the role of EWT versus SWT on adenoma detection rate (ADR) and other key quality metrics. In this prospective single-center study, patients undergoing colonoscopy were enrolled. EWT was calculated in real-time using an AI system with endoscopists blinded to the results. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonic Polyp, Colon Adenoma, Artificial Intelligence
- What is being tested?
- Endoscreen QC
- Type of treatment
- Medical device
- How many people
- 193 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
None listed.
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
Official title: Prospective Evaluation of Artificial Intelligence-assisted Monitoring of Effective Withdrawal Time on Adenoma Detection
This study prospectively evaluated the role of EWT versus SWT on adenoma detection rate (ADR) and other key quality metrics. In this prospective single-center study, patients undergoing colonoscopy were enrolled. EWT was calculated in real-time using an AI system with endoscopists blinded to the results. We performed multivariable analyses to assess the association of EWT and SWT with binary (e.g., ADR) and count outcomes (e.g., adenoma per colonoscopy [APC]), after adjusting for patient and procedural characteristics.
Read the detailed description
This was a prospective, single-center observational study designed to determine if an AI-powered metric, Effective Withdrawal Time (EWT), is a superior predictor of colonoscopy quality compared to the traditional Standard Withdrawal Time (SWT). All colonoscopies were performed by qualified endoscopists using high-definition white light video scopes. During the procedure, the scope is first advanced to the start of the large intestine (the cecum). The critical examination phase-the withdrawal-begins as the endoscopist slowly pulls the scope back out, meticulously inspecting the colon lining for abnormalities like polyps. It is during this withdrawal that the key metrics were measured. While SWT is a simple duration timed manually, the AI-measured EWT specifically quantifies the time of high-quality mucosal inspection, automatically excluding periods when the camera view is blurry, obscured, or moving too quickly. A crucial aspect of the methodology was that the endoscopists were blinded to the live EWT measurements to prevent the Hawthorne effect, where individuals alter their behaviour because they are being monitored. The study enrolled adults aged 40 and over, excluding patients with conditions that could confound the findings. The primary goal was to assess the independent impact of EWT on the Adenoma Detection Rate (ADR), a key benchmark based on the detection and removal of precancerous polyps for analysis. To achieve this, researchers used multivariable regression models to isolate EWT's effect from other variables and employed correlation tests to statistically compare whether EWT had a stronger relationship with detection quality than SWT
- Conditions
- Colonic Polyp, Colon Adenoma, Artificial Intelligence
- Being tested
- Endoscreen QC
- Keywords
- Colonic 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.
Endoscreen QCDevice
Artificial intelligence monitoring of effective withdrawal time
| Study group | Role | What they receive |
|---|---|---|
| AI group | AI monitoring of effective withdrawal time Receives: Device: Endoscreen QC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rates
Adenoma detection rates
Measured: During the colonoscopy
Secondary outcomes (7)
Polyp detection rate
Polyp detection rates of the colonoscopy
Measured: During that colonoscopy
Serrated lesion detection rate
Serrated lesion detection rates of that colonoscopy
Measured: During colonoscopy
Advanced adenoma detection rate
Advanced adenoma detection rates of that colonoscopy
Measured: During colonoscopy
Adenoma per colonoscopy
Adenoma per colonoscopy
Measured: During colonoscopy
Polyp per colonoscopy
Polyp per colonoscopy
Measured: During colonoscopy
Serrated lesion per colonoscopy
Serrated lesion per colonoscopy
Measured: During colonoscopy
Advanced adenoma per colonoscopy
Advanced adenoma per colonoscopy
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 posted2 Oct 2023
- 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colonic 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
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Lui Ka-Luen, The University of Hong Kong
- Investigators
- Ka Luen Thomas Lui, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06063720
- Sponsor's protocol ID
- AIeffectiveV3
- Status last verified
- Sep 2025
- First submitted
- 20 Sep 2023
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lui TKL, Lam CP, Tsui VW, Hui RW, To EW, Mak LL, Ko MK, Liu KS, Hui CK, Liu JJ, Xiao X, Leung WK. Prospective evaluation of artificial intelligence-assisted monitoring of the effective withdrawal time on adenoma detection. Intest Res. 2026 Mar 18. doi: 10.5217/ir.2025.00262. Online ahead of print.
PubMed 41844373
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Artificial Intelligence-assisted Monitoring of Effective Withdrawal Time on Adenoma Detection
- ClinicalTrials.gov ID
- NCT06063720
- Acronym / sponsor ID
- AIeffectiveV3
- Conditions
- Colonic Polyp, Colon Adenoma, Artificial Intelligence
- Keywords
- Colonic Polyp, Artificial intelligence, Withdrawal time
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 193 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
- 2 Oct 2023 (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.
This study prospectively evaluated the role of EWT versus SWT on adenoma detection rate (ADR) and other key quality metrics. In this prospective single-center study, patients undergoing colonoscopy were enrolled. EWT was calculated in real-time using an AI system with endoscopists blinded to the results. We performed multivariable analyses to assess the association of EWT and SWT with binary (e.g., ADR) and count outcomes (e.g., adenoma per colonoscopy [APC]), after adjusting for patient and procedural characteristics.
Detailed description
This was a prospective, single-center observational study designed to determine if an AI-powered metric, Effective Withdrawal Time (EWT), is a superior predictor of colonoscopy quality compared to the traditional Standard Withdrawal Time (SWT). All colonoscopies were performed by qualified endoscopists using high-definition white light video scopes. During the procedure, the scope is first advanced to the start of the large intestine (the cecum). The critical examination phase-the withdrawal-begins as the endoscopist slowly pulls the scope back out, meticulously inspecting the colon lining for abnormalities like polyps. It is during this withdrawal that the key metrics were measured. While SWT is a simple duration timed manually, the AI-measured EWT specifically quantifies the time of high-quality mucosal inspection, automatically excluding periods when the camera view is blurry, obscured, or moving too quickly. A crucial aspect of the methodology was that the endoscopists were blinded to the live EWT measurements to prevent the Hawthorne effect, where individuals alter their behaviour because they are being monitored. The study enrolled adults aged 40 and over, excluding patients with conditions that could confound the findings. The primary goal was to assess the independent impact of EWT on the Adenoma Detection Rate (ADR), a key benchmark based on the detection and removal of precancerous polyps for analysis. To achieve this, researchers used multivariable regression models to isolate EWT's effect from other variables and employed correlation tests to statistically compare whether EWT had a stronger relationship with detection quality than SWT
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AI group | – | Device: Endoscreen 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 (0 listed)
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 |
|---|---|---|
| Endoscreen QCArtificial intelligence monitoring of effective withdrawal time | Device | AI group |
Primary outcome
Adenoma detection rates
Time frame: During the colonoscopy
Adenoma detection rates
7 secondary outcomes
Polyp detection rate
Time frame: During that colonoscopy
Serrated lesion detection rate
Time frame: During colonoscopy
Advanced adenoma detection rate
Time frame: During colonoscopy
Adenoma per colonoscopy
Time frame: During colonoscopy
Polyp per colonoscopy
Time frame: During colonoscopy
Serrated lesion per colonoscopy
Time frame: During colonoscopy
Advanced adenoma per colonoscopy
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 10 Sep 2025.
- Derived from this study: PubMed 41844373Lui TKL, Lam CP, Tsui VW, Hui RW, To EW, Mak LL, Ko MK, Liu KS, Hui CK, Liu JJ, Xiao X, Leung WK. Prospective evaluation of artificial intelligence-assisted monitoring of the effective withdrawal time on adenoma detection. Intest Res. 2026 Mar 18. doi: 10.5217/ir.2025.00262. Online ahead of print.
- 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.
Ka Luen Thomas 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 Colonic 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 0 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 10 Sep 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 detection rates (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?
On the ClinicalTrials.gov record for NCT06063720, 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 10 Sep 2025.