Colorectal NeoplasmsNCT05013125
ENDO-AID Assisted Tandem Colonoscopy RCT
A study testing ENDO-AID CADe assisted Colonoscopy in people with Colorectal Neoplasms, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study hypothesizes that more adenomas will be detected using the ENDO-AID assisted Colonoscopy compared to conventional colonoscopy. A single-centre, randomized, same-day, back-to-back tandem colonoscopy trial comparing Adenoma Missed Rate and Adenoma Detection Rate in ENDO-AID assisted colonoscopy and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- ENDO-AID CADe assisted Colonoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteHong Kong
- Study dates
- 18 Aug 2021to 30 Apr 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18years or above
- Referred to endoscopy unit for diagnostic or surveillance colonoscopy
Who cannot join
- Familial history of Familial adenomatous polyposis / Hereditary non-polyposis colorectal cancer
- Known history of inflammatory bowel disease
- Known colitis or suspicion of colitis (inflammatory bowel disease, diverticulitis, infective colitis)
- Emergency endoscopy of any nature (eg gastrointestinal bleeding, colonic decompression)
- Previous incomplete colonoscopy (not including insufficient preparation) / difficult colonoscopy
- Patients referred for a therapeutic procedure or assessment of a known non-resected lesion
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- Patients with known palliative colorectal malignancy
- Patient with coagulopathy
- Patient with colostomy
- Patient with multiple co-morbidities (American Society of Anaesthesiologist >3)
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Surgery, Chinese University of Hong Kong
Shatin, New Territories
About this study
Official title: Assessment of Efficacy of ENDO-AID Assisted Colonoscopy in Adenoma Detection: a Single Centre Randomised Controlled Trial
This study hypothesizes that more adenomas will be detected using the ENDO-AID assisted Colonoscopy compared to conventional colonoscopy.
A single-centre, randomized, same-day, back-to-back tandem colonoscopy trial comparing Adenoma Missed Rate and Adenoma Detection Rate in ENDO-AID assisted colonoscopy and conventional colonoscopy.
Read the detailed description
Colorectal cancer is the third common cancer in the world and the commonest cancer in Hong Kong. Most sporadic colorectal cancers arise from benign polyps via adenoma-carcinoma sequence or the serrated polyp-carcinoma sequence. There are reports of unexpectedly high risk of interval carcinomas, as high as up to 9%, raising concerns about the effectiveness of colonoscopy in preventing colorectal cancers. Different techniques have been described to improve the area of mucosa visualised but lesions may still be missed due to failure of identification by the endoscopist.
Computer Aided diagnosis (CAD) assisted colonoscopy is becoming increasingly popular to address human error. Deep learning technology has surpassed human learning and advancement in technology now allows real-time Artificial Intelligence to assist colonoscopists in polyp detection.
- Conditions
- Colorectal Neoplasms
- Being tested
- ENDO-AID CADe assisted Colonoscopy
- Keywords
- Computer aided Polyp detection, Colonoscopy, Polyp detection, Colorectal polyps, Colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENDO-AID CADe assisted ColonoscopyDiagnostic test
ENDO-AID is a dedicated endoscopy Computer-Aided Diagnosis (CADe) system where suspicious lesions are automatically detected and highlighted on the main monitor in real-time, alerting the endoscopist during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Colonoscopy - ENDO-AID assisted Colonoscopy | No intervention | Patients will undergo usual colonoscopy as per usual practice, followed back to back by ENDO-AID assisted colonoscopy |
| ENDO-AID assisted Colonoscopy - ENDO-AID assisted Colonoscopy | Active comparator | Patients will undergo ENDO-AID assisted colonoscopy with all polyps treated as per usual practice, followed back to back by ENDO-AID assisted colonoscopy Receives: Diagnostic Test: ENDO-AID CADe assisted Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma missed rate
To compare the adenoma missed rate (AMR) between ENDO-AID assisted Colonoscopy and conventional colonoscopy. AMR is defined as the number of adenomas detected in the second pass colonoscopy divided by the total number of adenomas detected in both passes for the same patients.
Measured: End of study, about 1 year
Secondary outcomes (7)
Polyp missed rate
To compare the Polyp missed rate (PMR) between ENDO-AID assisted Colonoscopy and conventional colonoscopy. PMR is defined as the number of polyps detected in the second pass colonoscopy divided by the total number of polyps detected in both passes for the same patients.
Measured: End of study, about 1 year
Adenoma detection rate
To compare the Adenoma detection rate (ADR) between ENDO-AID assisted Colonoscopy and conventional colonoscopy for the first pass colonoscopy. ADR is defined as the proportion of patients with at least 1 adenoma detected in the first pass colonoscopy.
Measured: End of study, about 1 year
Patient missed rate
To compare the patient missed rate (PMR) between ENDO-AID assisted colonoscopy and conventional white light colonoscopy. PMR is defined as the number of patients in whom adenomas were detected for the first time during second pass colonoscopy divided by the number of patients with at least 1 adenoma detected.
Measured: End of study, about 1 year
Number of polyps removed
To compare the number of polyps removed between ENDO-AID assisted Colonoscopy and conventional white light colonoscopy
Measured: End of study, about 1 year
Baseline Parameters
Baseline Parameters will be compared, including withdrawal time and Boston Bowel Preparation Scale in the first colonoscopy procedures
Measured: End of study, about 1 year
Serious Adverse Events
To compare the Serious Adverse Events between ENDO-AID assisted Colonoscopy and conventional white light colonoscopy
Measured: At 30 days
Number of CAD assisted abnormality
Number of abnormalities highlighted on ENDO-AID and actual number of abnormalities found macroscopically and histologically
Measured: End of study, about 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start18 Aug 2021
- Primary completion17 Mar 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaori Futaba, Chinese University of Hong Kong
- Investigators
- Kaori Futaba, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05013125
- Sponsor's protocol ID
- CREC.2021.336
- Status last verified
- Apr 2024
- First submitted
- 26 Jul 2021
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Efficacy of ENDO-AID Assisted Colonoscopy in Adenoma Detection: a Single Centre Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05013125
- Acronym / sponsor ID
- CREC.2021.336
- Conditions
- Colorectal Neoplasms
- Keywords
- Computer aided Polyp detection, Colonoscopy, Polyp detection, Colorectal polyps, Colorectal cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 18 Aug 2021 (actual)
- Primary completion
- 17 Mar 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 19 Aug 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.
This study hypothesizes that more adenomas will be detected using the ENDO-AID assisted Colonoscopy compared to conventional colonoscopy.
A single-centre, randomized, same-day, back-to-back tandem colonoscopy trial comparing Adenoma Missed Rate and Adenoma Detection Rate in ENDO-AID assisted colonoscopy and conventional colonoscopy.
Detailed description
Colorectal cancer is the third common cancer in the world and the commonest cancer in Hong Kong. Most sporadic colorectal cancers arise from benign polyps via adenoma-carcinoma sequence or the serrated polyp-carcinoma sequence. There are reports of unexpectedly high risk of interval carcinomas, as high as up to 9%, raising concerns about the effectiveness of colonoscopy in preventing colorectal cancers. Different techniques have been described to improve the area of mucosa visualised but lesions may still be missed due to failure of identification by the endoscopist.
Computer Aided diagnosis (CAD) assisted colonoscopy is becoming increasingly popular to address human error. Deep learning technology has surpassed human learning and advancement in technology now allows real-time Artificial Intelligence to assist colonoscopists in polyp detection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Colonoscopy - ENDO-AID assisted Colonoscopy | No intervention | –Patients will undergo usual colonoscopy as per usual practice, followed back to back by ENDO-AID assisted colonoscopy |
| ENDO-AID assisted Colonoscopy - ENDO-AID assisted Colonoscopy | Active comparator | Diagnostic Test: ENDO-AID CADe assisted ColonoscopyPatients will undergo ENDO-AID assisted colonoscopy with all polyps treated as per usual practice, followed back to back by ENDO-AID assisted colonoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18years or above
- Referred to endoscopy unit for diagnostic or surveillance colonoscopy
Key exclusion criteria (11 listed)
- Familial history of Familial adenomatous polyposis / Hereditary non-polyposis colorectal cancer
- Known history of inflammatory bowel disease
- Known colitis or suspicion of colitis (inflammatory bowel disease, diverticulitis, infective colitis)
- Emergency endoscopy of any nature (eg gastrointestinal bleeding, colonic decompression)
- Previous incomplete colonoscopy (not including insufficient preparation) / difficult colonoscopy
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 CADe assisted ColonoscopyENDO-AID is a dedicated endoscopy Computer-Aided Diagnosis (CADe) system where suspicious lesions are automatically detected and highlighted on the main monitor in real-time, alerting the endoscopist during the procedure. | Diagnostic test | ENDO-AID assisted Colonoscopy - ENDO-AID assisted Colonoscopy |
Primary outcome
Adenoma missed rate
Time frame: End of study, about 1 year
To compare the adenoma missed rate (AMR) between ENDO-AID assisted Colonoscopy and conventional colonoscopy. AMR is defined as the number of adenomas detected in the second pass colonoscopy divided by the total number of adenomas detected in both passes for the same patients.
7 secondary outcomes
Polyp missed rate
Time frame: End of study, about 1 year
Adenoma detection rate
Time frame: End of study, about 1 year
Patient missed rate
Time frame: End of study, about 1 year
Number of polyps removed
Time frame: End of study, about 1 year
Baseline Parameters
Time frame: End of study, about 1 year
Serious Adverse Events
Time frame: At 30 days
Number of CAD assisted abnormality
Time frame: End of study, about 1 year
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 26 Apr 2024.
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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.
Kaori Futaba principal investigator
Chinese 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 ENDO-AID CADe assisted Colonoscopy in people with Colorectal Neoplasms, 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 11 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 26 Apr 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?
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?
Adenoma missed rate (time frame: End of study, about 1 year). 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 26 Apr 2024.