Screening ColonscopyENDOAID-PRONCT06251700
Longterm Effectiveness of Artificial Intelligence-assisted Colonoscopy on Adenoma Recurrence
A study testing ENDO-AID CADe in people with Screening Colonscopy, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
We hypothesize that AI-assisted colonoscopy can reduce post-colonoscopy neoplasia incidence after 3 years, over standard colonoscopy. Moreover, this protective effect may allow surveillance intervals to be lengthened, by modifying long-term outcome of high-risk subgroup. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Screening Colonscopy
- What is being tested?
- ENDO-AID CADe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 775 participants
- Where
- 1 siteHong Kong
- Study dates
- 24 Jan 2024to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects are eligible if:
- They underwent randomization to receive colonoscopy with/without CADe in ENDOAID-TRAIN study [NCT04838951]; (ii) They are fit and willing to undergo surveillance colonoscopy at year 3; (iii) Written informed consent obtained.
Who cannot join
- Subjects will be excluded from the study if they have any of the followings:
- Incomplete colonoscopy during index procedure; (ii) Known residual colorectal neoplasia not removed (except hyperplastic polyps); (iii) Underwent unscheduled interval colonoscopy before year 3; (iv) Contraindications to surveillance colonoscopy at year 3; (v) Advanced comorbid (American Society of Anesthesiologists grade 4 or above); (vi) History of CRC, hereditary polyposis syndrome or inflammatory bowel disease; (vii) History of colectomy at any time point.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong
Louis Lau
About this study
Official title: Longterm Effectiveness of Artificial Intelligence-assisted Colonoscopy on Adenoma Recurrence - a Prospective Longitudinal Follow-up of Randomized Controlled Trial
We hypothesize that AI-assisted colonoscopy can reduce post-colonoscopy neoplasia incidence after 3 years, over standard colonoscopy. Moreover, this protective effect may allow surveillance intervals to be lengthened, by modifying long-term outcome of high-risk subgroup.
Read the detailed description
Between April 2021 and July 2022, our group completed a parallel-group, randomized controlled trial in Hong Kong. [ENDOAID-TRAIN study; NCT04838951] 856 subjects undergoing colonoscopies were randomized 1:1 to receive colonoscopies with CADe (ENDO-AID, Olympus Co., Japan) or standard colonoscopies (control). Our study proved that AI-assisted colonoscopies could increase the overall ADR, especially small-to-medium size adenomas. It remains questionable whether the increased detection and removal of these non-advanced adenomas can be translated into any sustained long-term benefit. The impact of this AI-driven intensive surveillance on general population and healthcare system is also largely unknown. In this research project, we aim to assess the long-term effectiveness of AI-assisted colonoscopy on adenoma recurrence and PCCRC prevention, by conducting a real-world, prospective study with longitudinal extension from a randomized trial.
- Conditions
- Screening Colonscopy
- Being tested
- ENDO-AID CADe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENDO-AID CADeDevice
ENDO-AID CADe will be used during the withdrawal process of the colonscopy
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | CADe system will be used during withdrawal phase of colonscopy Receives: Device: ENDO-AID CADe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-colonoscopy adenomas at year 3
The primary endpoint is the incidence of post-colonoscopy adenomas at year 3, which is the composite of new occurrence and metachronous recurrence of adenomas during surveillance.
Measured: During the colonoscopy
Secondary outcomes (7)
Post-colonoscopy AA
Incidence of post-colonoscopy advanced adenomas
Measured: During the colonoscopy
Post-colonoscopy advanced neoplasms
Incidence of post-colonoscopy advanced neoplasms
Measured: During the colonoscopy
Post-colonoscopy SSL
Incidence of post-colonoscopy SSL
Measured: During the colonoscopy
Post-colonoscopy CRC
Incidence of post-colonoscopy CRC
Measured: During the colonoscopy
Post-colonoscopy adenomas and advanced adenomas
Number of post-colonoscopy adenomas and advanced adenomas
Measured: During the colonoscopy
Size and location of post-colonoscopy adenomas and advanced adenomas
Size and location of post-colonoscopy adenomas and advanced adenomas
Measured: During the colonoscopy
High-risk and low-risk group according to USMSTF guideline
Proportion of subjects re-classified as high-risk and low-risk groups according to USMSTF guideline
Measured: During the colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start24 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Screening ColonscopyStudies of the same condition, open and under way.
- More trials run by Chinese 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 775 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louis Ho Shing Lau, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251700
- Sponsor's protocol ID
- 2023.541
- Acronym
- ENDOAID-PRO
- Status last verified
- Oct 2024
- First submitted
- 1 Feb 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longterm Effectiveness of Artificial Intelligence-assisted Colonoscopy on Adenoma Recurrence - a Prospective Longitudinal Follow-up of Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06251700
- Acronym / sponsor ID
- ENDOAID-PRO / 2023.541
- Conditions
- Screening Colonscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 775 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 9 Feb 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.
We hypothesize that AI-assisted colonoscopy can reduce post-colonoscopy neoplasia incidence after 3 years, over standard colonoscopy. Moreover, this protective effect may allow surveillance intervals to be lengthened, by modifying long-term outcome of high-risk subgroup.
Detailed description
Between April 2021 and July 2022, our group completed a parallel-group, randomized controlled trial in Hong Kong. [ENDOAID-TRAIN study; NCT04838951] 856 subjects undergoing colonoscopies were randomized 1:1 to receive colonoscopies with CADe (ENDO-AID, Olympus Co., Japan) or standard colonoscopies (control). Our study proved that AI-assisted colonoscopies could increase the overall ADR, especially small-to-medium size adenomas. It remains questionable whether the increased detection and removal of these non-advanced adenomas can be translated into any sustained long-term benefit. The impact of this AI-driven intensive surveillance on general population and healthcare system is also largely unknown. In this research project, we aim to assess the long-term effectiveness of AI-assisted colonoscopy on adenoma recurrence and PCCRC prevention, by conducting a real-world, prospective study with longitudinal extension from a randomized trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Device: ENDO-AID CADeCADe system will be used during withdrawal phase of colonscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- They underwent randomization to receive colonoscopy with/without CADe in ENDOAID-TRAIN study [NCT04838951]; (ii) They are fit and willing to undergo surveillance colonoscopy at year 3; (iii) Written informed consent obtained.
Key exclusion criteria (2 listed)
- Incomplete colonoscopy during index procedure; (ii) Known residual colorectal neoplasia not removed (except hyperplastic polyps); (iii) Underwent unscheduled interval colonoscopy before year 3; (iv) Contraindications to surveillance colonoscopy at year 3; (v) Advanced comorbid (American Society of Anesthesiologists grade 4 or above); (vi) History of CRC, hereditary polyposis syndrome or inflammatory bowel disease; (vii) History of colectomy at any time point.
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 |
|---|---|---|
| ENDO-AID CADeENDO-AID CADe will be used during the withdrawal process of the colonscopy | Device | Intervention arm |
Primary outcome
Post-colonoscopy adenomas at year 3
Time frame: During the colonoscopy
The primary endpoint is the incidence of post-colonoscopy adenomas at year 3, which is the composite of new occurrence and metachronous recurrence of adenomas during surveillance.
7 secondary outcomes
Post-colonoscopy AA
Time frame: During the colonoscopy
Post-colonoscopy advanced neoplasms
Time frame: During the colonoscopy
Post-colonoscopy SSL
Time frame: During the colonoscopy
Post-colonoscopy CRC
Time frame: During the colonoscopy
Post-colonoscopy adenomas and advanced adenomas
Time frame: During the colonoscopy
Size and location of post-colonoscopy adenomas and advanced adenomas
Time frame: During the colonoscopy
High-risk and low-risk group according to USMSTF guideline
Time frame: During the colonoscopy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Screening Colonscopy
RecruitingObservational study
What Influence Re-participation in the Danish Colorectal Screening Program.
Colonoscopy, Screening Colonscopy
Active, not recruitingObservational study
Could Computerized Tomography be an Alternative to Colonoscopies for Screening for Colorectal Cancer?
Colo-rectal Cancer, Screening Colonscopy
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENDO-AID CADe in people with Screening Colonscopy, run by Chinese 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 29 Oct 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Felix Sia (26370428, felixsia@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-colonoscopy adenomas at year 3 (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 29 Oct 2024.