- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06063720
Effective Withdrawal Time and Adenoma Detection Rate
September 3, 2025 updated by: Dr. Lui Ka-Luen, The University of Hong Kong
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
193
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hong Kong, Hong Kong
- Queen Mary Hospital, The University of Hong Kong
-
-
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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
All patient will be recruited in Queen Mary Hospital, Hong Kong, China
Description
Inclusion Criteria: All adult patients, aged 40 or above, undergoing outpatient colonoscopy will be recruited
Exclusion Criteria:
- 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
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
AI group
AI monitoring of effective withdrawal time
|
Artificial intelligence monitoring of effective withdrawal time
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adenoma detection rates
Time Frame: During the colonoscopy
|
Adenoma detection rates
|
During the colonoscopy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Polyp detection rate
Time Frame: During that colonoscopy
|
Polyp detection rates of the colonoscopy
|
During that colonoscopy
|
|
Adenoma per colonoscopy
Time Frame: During colonoscopy
|
Adenoma per colonoscopy
|
During colonoscopy
|
|
Polyp per colonoscopy
Time Frame: During colonoscopy
|
Polyp per colonoscopy
|
During colonoscopy
|
|
Serrated lesion detection rate
Time Frame: During colonoscopy
|
Serrated lesion detection rates of that colonoscopy
|
During colonoscopy
|
|
Advanced adenoma detection rate
Time Frame: During colonoscopy
|
Advanced adenoma detection rates of that colonoscopy
|
During colonoscopy
|
|
Serrated lesion per colonoscopy
Time Frame: During colonoscopy
|
Serrated lesion per colonoscopy
|
During colonoscopy
|
|
Advanced adenoma per colonoscopy
Time Frame: During colonoscopy
|
Advanced adenoma per colonoscopy
|
During colonoscopy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ka Luen Thomas Lui, The University of Hong Kong
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)
November 1, 2023
Primary Completion (Actual)
September 30, 2024
Study Completion (Actual)
January 31, 2025
Study Registration Dates
First Submitted
September 20, 2023
First Submitted That Met QC Criteria
September 30, 2023
First Posted (Actual)
October 2, 2023
Study Record Updates
Last Update Posted (Estimated)
September 10, 2025
Last Update Submitted That Met QC Criteria
September 3, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIeffectiveV3
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
product manufactured in and exported from the U.S.
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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