Colonic AdenomaNCT05133544
Endocuff With or Without AI-assisted Colonoscopy
A study testing Endocuff with AI and AI alone in people with Colonic Adenoma and Colonic Polyp, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Colonoscopy is considered the gold standard for diagnosis of colonic polyps. However, it was reported that colonoscopy could still miss colonic polyps. Many attempts have been made to improve the detection rate of colonoscopy. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Colonic Adenoma, Colonic Polyp, Colonic Cancer
- What is being tested?
- Endocuff with AI and AI alone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 656 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 May 2022to Feb 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients, aged 40 or above, undergoing outpatient colonoscopy in the Queen Mary Hospital, Tung Wah Hospital and Tuen Mun Hospital in Hong Kong will be recruited.
Who cannot join
- Patients will be excluded if they have history of inflammatory bowel disease, colorectal cancer, previous bowel resection, Peutz-Jeghers syndrome, familial adenomatous polyposis or other polyposis syndromes, bleeding tendency or severe comorbid illnesses for which polypectomy is considered unsafe. Moreover, after randomization, if the cecum could not be intubated for various reasons or Boston Bowel Preparation Scale (BBPS) score is <2, these patients will be excluded
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong
Thomas K Lui, MBBS
About this study
Official title: Endocuff With or Without Artificial Intelligence-assisted Colonoscopy in Detection of Colorectal Adenoma: a Randomized Colonoscopy Trial
Colonoscopy is considered the gold standard for diagnosis of colonic polyps. However, it was reported that colonoscopy could still miss colonic polyps. Many attempts have been made to improve the detection rate of colonoscopy. Artificial intelligence (AI) is a promising new technique to improve detection rate of colonic adenoma. However, it remains uncertain whether whether the combined use of Endocuff and AI assisted examination could help to further improve the adenoma detection rate. This is a prospective randomized trial comparing the use of endocuff with AI, AI alone or conventional colonoscopy examination on adenoma detection rate.
Read the detailed description
TThis is a prospective randomized tandem colonoscopy trial comparing three different modes of colonoscopy techniques. The first group will use Endocuff (Olympus, Hong Kong) and AI assisted colonoscopy. The second group will use AI assisted colonoscopy alone and the third group will use standard high-definition white light colonoscopy.
Eligible patients will be randomly allocated in a 1:1:1 ratio to three groups. Patients will be stratified according to indications of colonoscopy (symptomatic vs screening/surveillance).
All examination will be performed with high-definition endoscopes (EVIS-EXERA 290 video system, Olympus Optical, Tokyo, Japan) under white light by experienced endoscopists. All endoscopists should have received training on the interpretation of real-time AI detection system as well as the Endocuff before performing study colonoscopy.
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 first withdrawn according to the group assigned. For group 1, the first withdrawal would be done with Endocuff and AI assistance. For group 2, the first withdrawal would be done under AI assistance only. For group 3, the first withdrawal would be done under standard high definition colonoscopy only.
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
- Conditions
- Colonic Adenoma, Colonic Polyp, Colonic Cancer
- Being tested
- Endocuff with AI, AI alone
- Keywords
- Artificial intelligence, Colonoscopy, Endocuff, Detection, Computer-aided
- Medical subject headings
- Colonic Polyps, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endocuff with AIDevice
Use of endocuff with computer assisted polyp detection
AI aloneDevice
Use of computer assisted polyp detection
| Study group | Role | What they receive |
|---|---|---|
| Endocuff- AI assisted colonoscopy | Active comparator | Endocuff (Olympus, Hong Kong) and AI assisted colonoscopy will be used Receives: Device: Endocuff with AI |
| AI-assisted colonoscopy | Active comparator | AI assisted colonoscopy will be used Receives: Device: AI alone |
| Conventional colonoscopy | No intervention | Conventional colonoscopy will be used without AI or Endocuff. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
The proportion of patients with at least one adenomas
Measured: One month after colonoscopy
Secondary outcomes (7)
Polyp detection rate
the proportion of patients with at least one polyp
Measured: One month after colonoscopy
Sessile serrated adenomas detection rate
The proportion of patients with at least one sessile serrated adenomas
Measured: One month after colonoscopy
Sessile serrated polyps detection rate
The proportion of patients with at least one sessile serrated polyps
Measured: One month after colonoscopy
Advanced adenoma detection rates
The proportion of patients with at least one advanced adenomas
Measured: One month after colonoscopy
Mean number of polyp per patient
The mean number of polyp per patient
Measured: One month after colonoscopy
Mean number of adenoma per patient
The mean number of adenoma per patient
Measured: One month after colonoscopy
Total number of polyp or adenoma per patient.
The total number of polyp or adenoma per patient.
Measured: One month after colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start1 May 2022
- Primary completionDec 2023 (estimated)
- Study completionFeb 2024 (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 Colonic 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 656 participants (estimated)
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
- Wai Keung Leung, MD, Study director, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133544
- Sponsor's protocol ID
- UW 20-647
- Status last verified
- Apr 2023
- First submitted
- 12 Nov 2021
- Last updated
- 6 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lui TK, Lam CP, To EW, Ko MK, Tsui VWM, Liu KS, Hui CK, Cheung MK, Mak LL, Hui RW, Wong SY, Seto WK, Leung WK. Endocuff With or Without Artificial Intelligence-Assisted Colonoscopy in Detection of Colorectal Adenoma: A Randomized Colonoscopy Trial. Am J Gastroenterol. 2024 Jul 1;119(7):1318-1325. doi: 10.14309/ajg.0000000000002684. Epub 2024 Feb 2.
PubMed 38305278
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endocuff With or Without Artificial Intelligence-assisted Colonoscopy in Detection of Colorectal Adenoma: a Randomized Colonoscopy Trial
- ClinicalTrials.gov ID
- NCT05133544
- Acronym / sponsor ID
- UW 20-647
- Conditions
- Colonic Adenoma, Colonic Polyp, Colonic Cancer
- Keywords
- Artificial intelligence, Colonoscopy, Endocuff, Detection, Computer-aided
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 656 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 24 Nov 2021 (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.
Colonoscopy is considered the gold standard for diagnosis of colonic polyps. However, it was reported that colonoscopy could still miss colonic polyps. Many attempts have been made to improve the detection rate of colonoscopy. Artificial intelligence (AI) is a promising new technique to improve detection rate of colonic adenoma. However, it remains uncertain whether whether the combined use of Endocuff and AI assisted examination could help to further improve the adenoma detection rate. This is a prospective randomized trial comparing the use of endocuff with AI, AI alone or conventional colonoscopy examination on adenoma detection rate.
Detailed description
TThis is a prospective randomized tandem colonoscopy trial comparing three different modes of colonoscopy techniques. The first group will use Endocuff (Olympus, Hong Kong) and AI assisted colonoscopy. The second group will use AI assisted colonoscopy alone and the third group will use standard high-definition white light colonoscopy.
Eligible patients will be randomly allocated in a 1:1:1 ratio to three groups. Patients will be stratified according to indications of colonoscopy (symptomatic vs screening/surveillance).
All examination will be performed with high-definition endoscopes (EVIS-EXERA 290 video system, Olympus Optical, Tokyo, Japan) under white light by experienced endoscopists. All endoscopists should have received training on the interpretation of real-time AI detection system as well as the Endocuff before performing study colonoscopy.
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 first withdrawn according to the group assigned. For group 1, the first withdrawal would be done with Endocuff and AI assistance. For group 2, the first withdrawal would be done under AI assistance only. For group 3, the first withdrawal would be done under standard high definition colonoscopy only.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Endocuff- AI assisted colonoscopy | Active comparator | Device: Endocuff with AIEndocuff (Olympus, Hong Kong) and AI assisted colonoscopy will be used |
| AI-assisted colonoscopy | Active comparator | Device: AI aloneAI assisted colonoscopy will be used |
| Conventional colonoscopy | No intervention | –Conventional colonoscopy will be used without AI or Endocuff. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients, aged 40 or above, undergoing outpatient colonoscopy in the Queen Mary Hospital, Tung Wah Hospital and Tuen Mun Hospital in Hong Kong will be recruited.
Key exclusion criteria (1 listed)
- Patients will be excluded if they have history of inflammatory bowel disease, colorectal cancer, previous bowel resection, Peutz-Jeghers syndrome, familial adenomatous polyposis or other polyposis syndromes, bleeding tendency or severe comorbid illnesses for which polypectomy is considered unsafe. Moreover, after randomization, if the cecum could not be intubated for various reasons or Boston Bowel Preparation Scale (BBPS) score is <2, these patients will be excluded
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 |
|---|---|---|
| Endocuff with AIUse of endocuff with computer assisted polyp detection | Device | Endocuff- AI assisted colonoscopy |
| AI aloneUse of computer assisted polyp detection | Device | AI-assisted colonoscopy |
Primary outcome
Adenoma detection rate
Time frame: One month after colonoscopy
The proportion of patients with at least one adenomas
7 secondary outcomes
Polyp detection rate
Time frame: One month after colonoscopy
Sessile serrated adenomas detection rate
Time frame: One month after colonoscopy
Sessile serrated polyps detection rate
Time frame: One month after colonoscopy
Advanced adenoma detection rates
Time frame: One month after colonoscopy
Mean number of polyp per patient
Time frame: One month after colonoscopy
Mean number of adenoma per patient
Time frame: One month after colonoscopy
Total number of polyp or adenoma per patient.
Time frame: One month after colonoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Derived from this study: PubMed 38305278Lui TK, Lam CP, To EW, Ko MK, Tsui VWM, Liu KS, Hui CK, Cheung MK, Mak LL, Hui RW, Wong SY, Seto WK, Leung WK. Endocuff With or Without Artificial Intelligence-Assisted Colonoscopy in Detection of Colorectal Adenoma: A Randomized Colonoscopy Trial. Am J Gastroenterol. 2024 Jul 1;119(7):1318-1325. doi: 10.14309/ajg.0000000000002684. Epub 2024 Feb 2.
- 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.
Wai Keung Leung, MD study director
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?
A study testing Endocuff with AI and AI alone in people with Colonic Adenoma and Colonic Polyp, 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 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: status not confirmed, as of the sponsor's last update on 6 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ka Luen, Thomas Lui, MBBS (22554048, klluitc@yahoo.com.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma detection rate (time frame: One month after 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 NCT05133544, 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 6 Apr 2023.