Colon AdenomaNCT04294355
Artificial Intelligence-assisted Colonoscopy on Detection of Missed Proximal Lesions
A study testing Artificial intelligence-Assisted colonoscopy and Conventional colonoscopy in people with Colon Adenoma and Colon Polyp, run by The University of Hong Kong at 3 sites in 3 countries.
Trial summary
This is a prospective multi-center randomized study is to determine whether the use of artificial intelligence (AI)-assistance could reduce the miss rates of polyps and adenomas in the proximal colon during tandem examination Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colon Adenoma, Colon Polyp
- What is being tested?
- Artificial intelligence-Assisted colonoscopy and Conventional colonoscopy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Mar 2021to 15 Apr 2022
- Phase
- Interventional
- 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
Who may be able to join
- All adult patients, aged 40 or above, undergoing outpatient colonoscopy in the participating centers 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.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Artificial Intelligence-assisted Colonoscopy Versus Conventional Colonoscopy for Missed Lesions in the Proximal Colon: A Prospective Multi-center Randomized Study in Asia
This is a prospective multi-center randomized study is to determine whether the use of artificial intelligence (AI)-assistance could reduce the miss rates of polyps and adenomas in the proximal colon during tandem examination
Read the detailed description
Centers
- Queen Mary Hospital, Hong Kong, China (Co-ordinating Center)
- Tan Tock Seng Hospital, Singapore, Singapore
- Institute of Gastroenterology and Hepatology, Vietnam Union of Science and Technology Association, Hanoi, Vietnam
Study population
Inclusion:
All adult patients, aged 40 or above, undergoing outpatient colonoscopy in the participating centers will be recruited.
Exclusion:
- 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.
Post-randomization exclusion:
- Cecum could not be intubated for various reasons
- Boston Bowel Preparation Scale (BBPS) score of the proximal colon is <2
Study design This is a prospective randomized trial comparing the miss rates of proximal colonic lesions by AI assisted colonoscopy or conventional colonoscopy (Fig. 1). The study will be conducted in the Endoscopy Centre of the participating hospitals.
Randomization Eligible patients in each center will be randomly allocated in a 1:1 ratio to undergo tandem colonoscopy of the proximal colon first with AI-assistance and follow by conventional white light colonoscopy (Group 1) or conventional white light colonoscopy without AI assistance follow by conventional colonoscopy (Group 2). Proximal colon refers to colonic segment proximal to the splenic flexure. Randomization will be conducted in blocks of 4 by computer generated random sequences and stratified according to indications of colonoscopy (symptomatic vs screening/surveillance). Patients will be blinded to the group assignment.
- Conditions
- Colon Adenoma, Colon Polyp
- Being tested
- Artificial intelligence-Assisted colonoscopy, Conventional colonoscopy
- Keywords
- Colonoscopy, Artificial intelligence
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial intelligence-Assisted colonoscopyDevice
Artificial intelligence-Assisted colonoscopy for detection of colonic polyp
Conventional colonoscopyProcedure or surgery
Conventional colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Artificial intelligence-Assisted colonoscopy | Experimental | Tandem colonoscopy of proximal colon assisted with artificial intelligence followed by conventional colonoscopy Receives: Device: Artificial intelligence-Assisted colonoscopy; Procedure: Conventional colonoscopy |
| Conventional colonoscopy | Active comparator | Tandem conventional colonoscopy of proximal colon followed by usual conventional colonoscopy Receives: Procedure: Conventional colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proximal adenoma missed rate
The proportion of patients with missed adenomas detected in the second examination only
Measured: One day
Secondary outcomes (3)
Proximal polyp missed rate
The proportion of patients with missed adenomas detected in the second examination only
Measured: One day
Proximal adenoma detection rate
The proportion of patients with at least one adenoma
Measured: One day
Proximal polyp detection
The proportion of patients with at least one polyp
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start1 Mar 2021
- Primary completion31 Mar 2022
- Study completion15 Apr 2022
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 Colon AdenomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Tan Tock Seng Hospital, Institute of Gastroenterology and Hepatology, Vietnam
- Responsible party
- Sponsor
- Investigators
- Ka Luen, Thomas Lui, MBBS, Principal investigator, Queen Mary Hospital, the University of Hong KongWai Keung Leung, MD, Study director, Queen Mary Hospital, the University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294355
- Sponsor's protocol ID
- UW 19-713
- Status last verified
- Apr 2022
- First submitted
- 2 Mar 2020
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lui TKL, Hang DV, Tsao SKK, Hui CKY, Mak LLY, Ko MKL, Cheung KS, Thian MY, Liang R, Tsui VWM, Yeung CK, Dao LV, Leung WK. Computer-assisted detection versus conventional colonoscopy for proximal colonic lesions: a multicenter, randomized, tandem-colonoscopy study. Gastrointest Endosc. 2023 Feb;97(2):325-334.e1. doi: 10.1016/j.gie.2022.09.020. Epub 2022 Oct 5.
PubMed 36208795
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-assisted Colonoscopy Versus Conventional Colonoscopy for Missed Lesions in the Proximal Colon: A Prospective Multi-center Randomized Study in Asia
- ClinicalTrials.gov ID
- NCT04294355
- Acronym / sponsor ID
- UW 19-713
- Conditions
- Colon Adenoma, Colon Polyp
- Keywords
- Colonoscopy, Artificial intelligence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Tan Tock Seng Hospital, Institute of Gastroenterology and Hepatology, Vietnam
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 4 Mar 2020 (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 is a prospective multi-center randomized study is to determine whether the use of artificial intelligence (AI)-assistance could reduce the miss rates of polyps and adenomas in the proximal colon during tandem examination
Detailed description
Centers
- Queen Mary Hospital, Hong Kong, China (Co-ordinating Center)
- Tan Tock Seng Hospital, Singapore, Singapore
- Institute of Gastroenterology and Hepatology, Vietnam Union of Science and Technology Association, Hanoi, Vietnam
Study population
Inclusion:
All adult patients, aged 40 or above, undergoing outpatient colonoscopy in the participating centers will be recruited.
Exclusion:
- 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.
Post-randomization exclusion:
- Cecum could not be intubated for various reasons
- Boston Bowel Preparation Scale (BBPS) score of the proximal colon is <2
Study design This is a prospective randomized trial comparing the miss rates of proximal colonic lesions by AI assisted colonoscopy or conventional colonoscopy (Fig. 1). The study will be conducted in the Endoscopy Centre of the participating hospitals.
Randomization Eligible patients in each center will be randomly allocated in a 1:1 ratio to undergo tandem colonoscopy of the proximal colon first with AI-assistance and follow by conventional white light colonoscopy (Group 1) or conventional white light colonoscopy without AI assistance follow by conventional colonoscopy (Group 2). Proximal colon refers to colonic segment proximal to the splenic flexure. Randomization will be conducted in blocks of 4 by computer generated random sequences and stratified according to indications of colonoscopy (symptomatic vs screening/surveillance). Patients will be blinded to the group assignment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective randomized design
| Arm | Type | Receives |
|---|---|---|
| Artificial intelligence-Assisted colonoscopy | Experimental | Device: Artificial intelligence-Assisted colonoscopy, Procedure: Conventional colonoscopyTandem colonoscopy of proximal colon assisted with artificial intelligence followed by conventional colonoscopy |
| Conventional colonoscopy | Active comparator | Procedure: Conventional colonoscopyTandem conventional colonoscopy of proximal colon followed by usual conventional colonoscopy |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients, aged 40 or above, undergoing outpatient colonoscopy in the participating centers will be recruited
Key exclusion criteria (5 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 |
|---|---|---|
| Artificial intelligence-Assisted colonoscopyArtificial intelligence-Assisted colonoscopy for detection of colonic polyp | Device | Artificial intelligence-Assisted colonoscopy |
| Conventional colonoscopyConventional colonoscopy | Procedure or surgery | Artificial intelligence-Assisted colonoscopy, Conventional colonoscopy |
Primary outcome
Proximal adenoma missed rate
Time frame: One day
The proportion of patients with missed adenomas detected in the second examination only
3 secondary outcomes
Proximal polyp missed rate
Time frame: One day
Proximal adenoma detection rate
Time frame: One day
Proximal polyp detection
Time frame: One day
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 21 Apr 2022.
- Derived from this study: PubMed 36208795Lui TKL, Hang DV, Tsao SKK, Hui CKY, Mak LLY, Ko MKL, Cheung KS, Thian MY, Liang R, Tsui VWM, Yeung CK, Dao LV, Leung WK. Computer-assisted detection versus conventional colonoscopy for proximal colonic lesions: a multicenter, randomized, tandem-colonoscopy study. Gastrointest Endosc. 2023 Feb;97(2):325-334.e1. doi: 10.1016/j.gie.2022.09.020. Epub 2022 Oct 5.
- Individual participant dataSharing planned: No
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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, MBBS principal investigator
Queen Mary Hospital, the University of Hong Kong
Wai Keung Leung, MD study director
Queen Mary Hospital, the University of Hong Kong
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial intelligence-Assisted colonoscopy and Conventional colonoscopy in people with Colon Adenoma and Colon Polyp, run by The University of Hong Kong at 3 sites in 3 countries.
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 5 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 21 Apr 2022. 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 China, Singapore, Vietnam. 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?
Proximal adenoma missed rate (time frame: One day). 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 NCT04294355, 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 21 Apr 2022.