AdenomaAIDENNCT05414448
Combination of Artificial Intelligence and Mucosal Exposure Device to Enhance Colorectal Neoplasia Detection
A study testing ENDOCUFF in people with Adenoma and Colorectal Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The investigators hypothesize that the combined use of CADe system (ENDOAID) and mucosal exposure device (Endocuff Vision®) would improve the adenoma detection rate when compared to CADe system alone. Read more about this study
- Who is it for?
- Ages 45 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Adenoma, Colorectal Cancer, Colorectal Neoplasms
- What is being tested?
- ENDOCUFF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,726 participants
- Where
- 1 siteHong Kong
- Study dates
- 7 Mar 2023to 31 Dec 2025
- 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 45 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 45-85 years old;
- They require elective colonoscopy for colorectal cancer screening, polyp surveillance, or investigation of symptoms such as anemia or altered bowel habit;
- Written informed consent obtained.
Who cannot join
- Contraindication to colonoscopy (e.g. intestinal obstruction or perforation)
- Contraindication or conditions precluding polyp resection (e.g. active gastrointestinal bleeding, uninterrupted anticoagulation or dual antiplatelets)
- Staged procedure for polypectomy or biopsy of known unresected lesions
- Previous surgical resection of colon
- Personal history of colorectal cancer
- Personal history of familial polyposis syndrome
Show all 10Show fewer
- Personal history of inflammatory bowel disease
- Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above)
- Pregnancy
- Unable to obtain informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combination of Artificial Intelligence (ENDOAID) and Mucosal Exposure Device (ENDOCUFF) to Enhance Colorectal Neoplasia Detection: a Randomized Controlled Trial
The investigators hypothesize that the combined use of CADe system (ENDOAID) and mucosal exposure device (Endocuff Vision®) would improve the adenoma detection rate when compared to CADe system alone.
Read the detailed description
High polyp miss rates were reported in standard colonoscopies. As a result, a significant proportion of interval CRC was attributed to the missed lesions during index colonoscopy. Risk factors of missed lesions included proximal location, serrate or flat morphology, poor bowel preparation, short withdrawal time and endoscopist experience.
To overcome this pitfall, various methods were developed to improve adenoma detection rate (ADR), including distal attachment devices. Among the mucosal exposure devices, Endocuff Vision® was shown to be superior than conventional colonoscopies.
Recently, artificial intelligence and automatic computer-aided polyp detection (CADe) systems have developed rapidly and revolutionized the medical field. Nevertheless, there was a potential limitation of 'blind spot' if the endoscopist failed to expose the colonic mucosa adequately leading to missed lesions. To date, no available data or ongoing clinical trial was reported regarding the combined use of CADe and mucosal exposure devices. It may enhance the performance of CADe and provide a novel definitive solution to this unaddressed yet important clinical problem.
In this prospective parallel randomized controlled trial, we aim to evaluate the impact of combined use of a new CADe system (ENDOAID) and mucosal exposure device (Endocuff Vision®) on colorectal neoplasia detection.
- Conditions
- Adenoma, Colorectal Cancer, Colorectal Neoplasms
- Being tested
- ENDOCUFF
- Medical subject headings
- Adenoma, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENDOCUFFDevice
ENDOCUFF mucousal exposure device will be used during withdrawal process of the colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| ENDOAID | No intervention | CADe system will be used during withdrawal phase of colonoscopy. |
| ENDOAID with ENDOCUFF | Experimental | CADe system and mucosal exposure device (ENDOCUFF) will be used during withdrawal phase of colonoscopy. Receives: Device: ENDOCUFF |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADR
adenoma detection rate
Measured: During the colonoscopy
Secondary outcomes (11)
ADR for adenomas of different sizes
<5mm, 5-10mm, >10mm
Measured: During the colonoscopy
ADR for adenomas of different colonic segments
caecum, ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid colon, rectum
Measured: During the colonoscopy
Mean number of adenomas per colonoscopy
Mean number of adenomas per colonoscopy
Measured: During the colonoscopy
Advanced adenoma detection rate
Advanced adenoma detection rate
Measured: During the colonoscopy
Sessile serrated lesion (SSL) detection rate
Sessile serrated lesion (SSL) detection rate
Measured: During the colonoscopy
Polyp detection rate
Polyp detection rate
Measured: During the colonoscopy
Non-neoplastic resection rate
defined as absence of adenoma or SSL or cancer within resected specimen
Measured: During the colonoscopy
Caecal intubation time
Caecal intubation time
Measured: During the colonoscopy
Withdrawal time
excluding interventions
Measured: During the colonoscopy
Total procedural time
Total procedural time
Measured: During the colonoscopy
False positive rate
defined as computer artifacts due to colonic mucosal wall or bowel content lasting for >2 seconds
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 posted10 Jun 2022
- Study start7 Mar 2023
- Primary completion7 Jul 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenomaStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,726 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Augsburg, Changi General Hospital
- Responsible party
- Principal investigator, Louis Ho Shing Lau, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414448
- Sponsor's protocol ID
- CREC2022.152
- Acronym
- AIDEN
- Status last verified
- Apr 2026
- First submitted
- 8 Jun 2022
- Last updated
- 22 Apr 2026
- 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 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Artificial Intelligence (ENDOAID) and Mucosal Exposure Device (ENDOCUFF) to Enhance Colorectal Neoplasia Detection: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05414448
- Acronym / sponsor ID
- AIDEN / CREC2022.152
- Conditions
- Adenoma, Colorectal Cancer, Colorectal Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,726 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- University Hospital Augsburg, Changi General Hospital
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 7 Jul 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 10 Jun 2022 (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.
The investigators hypothesize that the combined use of CADe system (ENDOAID) and mucosal exposure device (Endocuff Vision®) would improve the adenoma detection rate when compared to CADe system alone.
Detailed description
High polyp miss rates were reported in standard colonoscopies. As a result, a significant proportion of interval CRC was attributed to the missed lesions during index colonoscopy. Risk factors of missed lesions included proximal location, serrate or flat morphology, poor bowel preparation, short withdrawal time and endoscopist experience.
To overcome this pitfall, various methods were developed to improve adenoma detection rate (ADR), including distal attachment devices. Among the mucosal exposure devices, Endocuff Vision® was shown to be superior than conventional colonoscopies.
Recently, artificial intelligence and automatic computer-aided polyp detection (CADe) systems have developed rapidly and revolutionized the medical field. Nevertheless, there was a potential limitation of 'blind spot' if the endoscopist failed to expose the colonic mucosa adequately leading to missed lesions. To date, no available data or ongoing clinical trial was reported regarding the combined use of CADe and mucosal exposure devices. It may enhance the performance of CADe and provide a novel definitive solution to this unaddressed yet important clinical problem.
In this prospective parallel randomized controlled trial, we aim to evaluate the impact of combined use of a new CADe system (ENDOAID) and mucosal exposure device (Endocuff Vision®) on colorectal neoplasia detection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ENDOAID | No intervention | –CADe system will be used during withdrawal phase of colonoscopy. |
| ENDOAID with ENDOCUFF | Experimental | Device: ENDOCUFFCADe system and mucosal exposure device (ENDOCUFF) will be used during withdrawal phase of colonoscopy. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 45-85 years old;
- They require elective colonoscopy for colorectal cancer screening, polyp surveillance, or investigation of symptoms such as anemia or altered bowel habit;
- Written informed consent obtained.
Key exclusion criteria (10 listed)
- Contraindication to colonoscopy (e.g. intestinal obstruction or perforation)
- Contraindication or conditions precluding polyp resection (e.g. active gastrointestinal bleeding, uninterrupted anticoagulation or dual antiplatelets)
- Staged procedure for polypectomy or biopsy of known unresected lesions
- Previous surgical resection of colon
- Personal history of colorectal cancer
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 |
|---|---|---|
| ENDOCUFFENDOCUFF mucousal exposure device will be used during withdrawal process of the colonoscopy. | Device | ENDOAID with ENDOCUFF |
Primary outcome
ADR
Time frame: During the colonoscopy
adenoma detection rate
11 secondary outcomes
ADR for adenomas of different sizes
Time frame: During the colonoscopy
ADR for adenomas of different colonic segments
Time frame: During the colonoscopy
Mean number of adenomas per colonoscopy
Time frame: During the colonoscopy
Advanced adenoma detection rate
Time frame: During the colonoscopy
Sessile serrated lesion (SSL) detection rate
Time frame: During the colonoscopy
Polyp detection rate
Time frame: During the colonoscopy
Non-neoplastic resection rate
Time frame: During the colonoscopy
Caecal intubation time
Time frame: During the colonoscopy
Withdrawal time
Time frame: During the colonoscopy
Total procedural time
Time frame: During the colonoscopy
False positive rate
Time frame: During the 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 22 Apr 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Adenoma and Colorectal Cancer, 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 3 inclusion and 10 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 22 Apr 2026. 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?
ADR (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 22 Apr 2026.