Colonic PolypCOPILOTNCT05822895
Review of the Impact of a Computer-aided Real-time Polyp Detection System on Adult Colonoscopy
An observational study of Colonic Polyp, run by Sengkang General Hospital at 1 site in Singapore.
Trial summary
Background: Removal of adenomatous polyps during colonoscopy is associated with long-term prevention of colorectal cancer-related deaths. Recently, there have been much interest in the use of artificial intelligence (AI) platforms to augment the routine endoscopic assessment of the colon to enhance adenoma detection… Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Colonic Polyp
- What is being tested?
- CADe enabled programme (GI Genius)
- Type of treatment
- Medical device
- How many people
- 764 participants
- Where
- 1 siteSingapore
- Study dates
- 2 Jan 2023to 31 Dec 2031
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will be a single-institution cohort study, conducted over a 2-year period. We will recruit patients prospectively who would have their colonoscopy performed with AI guidance from the GI Genius, which is a standard of care feature in the endoscopy rooms fitted with the GI Genius, and compare it against historical data when the AI technology was not available (Jan 2018-Jan 2021). This historical data has already been collected as part of a published audit performed for SKH's endoscopy. The data collected for this historical cohort are from an anonymised database collected from OTMU (who is not involved in the study).
Who may be able to join
- all adult patients going for colonoscopy in the our institution
Who cannot join
- Patients with incomplete or failed colonoscopy, flexible sigmoidoscopy, colonoscopy done after previous colorectal cancers or previous colonic resections, patients with poor bowel preparation, when deemed by the endoscopist to have an incomplete assessment of the colon
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
Sengkang General Hospital
Singapore, Singapore, 544886
Frederick H Koh, FRCSEd, 84281117 ext. 65, frederick.koh.h.x@singhealth.com.sg
About this study
Official title: A Comprehensive Review of the Impact of a COmPuter-aIded reaL-time pOlyp deTection System on Adult Colonoscopy (COPILOT Study) - a Single Institution Adoption Experience
Background:
Removal of adenomatous polyps during colonoscopy is associated with long-term prevention of colorectal cancer-related deaths. Recently, there have been much interest in the use of artificial intelligence (AI) platforms to augment the routine endoscopic assessment of the colon to enhance adenoma detection rate (ADR). To date, computer assisted detection of polyps (CADe) have been shown to be safe, with a significant increase in ADR, without any concomitant increase in post-procedural complications.
Read more
Aims:
The investigators aim to evaluate the use of GI GeniusTM Intelligent Endoscopy Module in a multi-ethnic Asian population (Singapore) to increase in ADR and adenoma detected per colonoscopy (ADPC)to justify its effectiveness as an adjunct in polyp detection and training for colonoscopy.
Methods:
This study will be a single-institution cohort study, conducted over a 2-year period. Sengkang General Hospital (SKH) does an estimated 12,500 colonoscopies per year, with an average of 1,040 colonoscopies performed every month. Thus, given the case volume, the investigators expect to detect differences in ADR amongst endoscopists if any during this study period.
As part of the subgroup analysis, the investigators also aim to compare the ADR rates of trainee endoscopists with and without the GI GeniusTM Intelligent Endoscopy Module to ascertain its utility as an education tool/training adjunct
Read the detailed description
This study will be a single-institution cohort study, conducted over a 2-year period. The investigators will recruit patients prospectively who would have their colonoscopy performed with AI guidance from the GI Genius, which is a standard of care feature in the endoscopy rooms fitted with the GI Genius, and compare it against historical data when the AI technology was not available (Jan 2018-Jan 2021). This historical data has already been collected as part of a published audit performed for SKH's endoscopy. The data collected for this historical cohort are from an anonymised database collected from Operating Theatre Management Unit (OTMU) (who is not involved in the study).
For the prospective cohort undergoing AI aided endoscopy (1/4/2023 - 31/3/2025):
This will include all adult patients going for colonoscopy in the our institution. Patients with incomplete or failed colonoscopy, flexible sigmoidoscopy, colonoscopy done after previous colorectal cancers or previous colonic resections, patients with poor bowel preparation, when deemed by the endoscopist to have an incomplete assessment of the colon, will be excluded from the analysis.
patient demographical data, procedural related data as well as histology from histological reports from their colonoscopy would be collected by research coordinators in order to ascertain ADR, Adenoma Detection Per Colonoscopy (ADPC) and Polyp Detection Rate (PDR).
These coordinators are independent of the study team and will not be part of the analysis of the data. In order to have an effective barrier (for the study team not to be able to identify the patients from the data collected), therefore the coordinators act as a trusted independent party who will extract/de-identify the data before it is handed to the study team for analysis of the ADR ADPC and PDR. The study team will not attempt to re- identify the patients back.
Analysis of data:
Subsequent analysis will be conducted at every 3 months by reviewing for the absolute ADR and ADPC amongst endoscopists by the study team. By comparing these prospectively collected data with the historical cohort data, the investigators would be able to evaluate the effectiveness of the GI Genius in improving the ADR, PDR and ADPC. Cost analysis can also be done to analyse the cost effectiveness of the added AI feature.
- Conditions
- Colonic Polyp
- Being tested
- CADe enabled programme (GI Genius)
- Keywords
- Colonic polyp, colonoscopy, artificial intelligence, implementation science
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CADe enabled programme (GI Genius)Device
CADe enabled programme (GI Genius)
| Study group | Role | What they receive |
|---|---|---|
| Computer-aided polyp detection | patients undergoing colonoscopy with CADe enabled programme Receives: Device: CADe enabled programme (GI Genius) | |
| without CADe | patients undergoing colonoscopy without CADe enabled programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADR
Adenoma detection rate
Measured: 2 weeks for Histological results to return
Secondary outcomes (1)
ADPC
Adenoma detection per colonscopy rate
Measured: 2 weeks, for histological results to return
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start2 Jan 2023
- Primary completion30 Jun 2030 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PolypStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 764 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Sengkang General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Koh Hong Xiang Frederick, Sengkang General Hospital
- Investigators
- Frederick H Koh, FRCSEd, Principal investigator, Sengkang General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822895
- Sponsor's protocol ID
- 2022/2695
- Acronym
- COPILOT
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2023
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Review of the Impact of a COmPuter-aIded reaL-time pOlyp deTection System on Adult Colonoscopy (COPILOT Study) - a Single Institution Adoption Experience
- ClinicalTrials.gov ID
- NCT05822895
- Acronym / sponsor ID
- COPILOT / 2022/2695
- Conditions
- Colonic Polyp
- Keywords
- Colonic polyp, colonoscopy, artificial intelligence, implementation science
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 764 participants (estimated)
- Lead sponsor
- Sengkang General HospitalUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 21 Apr 2023 (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.
Background:
Removal of adenomatous polyps during colonoscopy is associated with long-term prevention of colorectal cancer-related deaths. Recently, there have been much interest in the use of artificial intelligence (AI) platforms to augment the routine endoscopic assessment of the colon to enhance adenoma detection rate (ADR). To date, computer assisted detection of polyps (CADe) have been shown to be safe, with a significant increase in ADR, without any concomitant increase in post-procedural complications.
Aims:
The investigators aim to evaluate the use of GI GeniusTM Intelligent Endoscopy Module in a multi-ethnic Asian population (Singapore) to increase in ADR and adenoma detected per colonoscopy (ADPC)to justify its effectiveness as an adjunct in polyp detection and training for colonoscopy.
Methods:
This study will be a single-institution cohort study, conducted over a 2-year period. Sengkang General Hospital (SKH) does an estimated 12,500 colonoscopies per year, with an average of 1,040 colonoscopies performed every month. Thus, given the case volume, the investigators expect to detect differences in ADR amongst endoscopists if any during this study period.
As part of the subgroup analysis, the investigators also aim to compare the ADR rates of trainee endoscopists with and without the GI GeniusTM Intelligent Endoscopy Module to ascertain its utility as an education tool/training adjunct
Detailed description
This study will be a single-institution cohort study, conducted over a 2-year period. The investigators will recruit patients prospectively who would have their colonoscopy performed with AI guidance from the GI Genius, which is a standard of care feature in the endoscopy rooms fitted with the GI Genius, and compare it against historical data when the AI technology was not available (Jan 2018-Jan 2021). This historical data has already been collected as part of a published audit performed for SKH's endoscopy. The data collected for this historical cohort are from an anonymised database collected from Operating Theatre Management Unit (OTMU) (who is not involved in the study).
For the prospective cohort undergoing AI aided endoscopy (1/4/2023 - 31/3/2025):
This will include all adult patients going for colonoscopy in the our institution. Patients with incomplete or failed colonoscopy, flexible sigmoidoscopy, colonoscopy done after previous colorectal cancers or previous colonic resections, patients with poor bowel preparation, when deemed by the endoscopist to have an incomplete assessment of the colon, will be excluded from the analysis.
patient demographical data, procedural related data as well as histology from histological reports from their colonoscopy would be collected by research coordinators in order to ascertain ADR, Adenoma Detection Per Colonoscopy (ADPC) and Polyp Detection Rate (PDR).
These coordinators are independent of the study team and will not be part of the analysis of the data. In order to have an effective barrier (for the study team not to be able to identify the patients from the data collected), therefore the coordinators act as a trusted independent party who will extract/de-identify the data before it is handed to the study team for analysis of the ADR ADPC and PDR. The study team will not attempt to re- identify the patients back.
Analysis of data:
Subsequent analysis will be conducted at every 3 months by reviewing for the absolute ADR and ADPC amongst endoscopists by the study team. By comparing these prospectively collected data with the historical cohort data, the investigators would be able to evaluate the effectiveness of the GI Genius in improving the ADR, PDR and ADPC. Cost analysis can also be done to analyse the cost effectiveness of the added AI feature.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer-aided polyp detection | – | Device: CADe enabled programme (GI Genius)patients undergoing colonoscopy with CADe enabled programme |
| without CADe | – | –patients undergoing colonoscopy without CADe enabled programme |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be a single-institution cohort study, conducted over a 2-year period. We will recruit patients prospectively who would have their colonoscopy performed with AI guidance from the GI Genius, which is a standard of care feature in the endoscopy rooms fitted with the GI Genius, and compare it against historical data when the AI technology was not available (Jan 2018-Jan 2021). This historical data has already been collected as part of a published audit performed for SKH's endoscopy. The data collected for this historical cohort are from an anonymised database collected from OTMU (who is not involved in the study).
Key inclusion criteria (1 listed)
- all adult patients going for colonoscopy in the our institution
Key exclusion criteria (1 listed)
- Patients with incomplete or failed colonoscopy, flexible sigmoidoscopy, colonoscopy done after previous colorectal cancers or previous colonic resections, patients with poor bowel preparation, when deemed by the endoscopist to have an incomplete assessment of the colon
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 |
|---|---|---|
| CADe enabled programme (GI Genius)CADe enabled programme (GI Genius) | Device | Computer-aided polyp detection |
Primary outcome
ADR
Time frame: 2 weeks for Histological results to return
Adenoma detection rate
1 secondary outcome
ADPC
Time frame: 2 weeks, for histological results to return
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 4 May 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.
Frederick H Koh, FRCSEd principal investigator
Sengkang General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonic Polyp, run by Sengkang General Hospital at 1 site in Singapore.
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: looking for participants now, as of the sponsor's last update on 4 May 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 Singapore. 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 Frederick H Koh, FRCSEd (+65-84281117, frederick.koh.h.x@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADR (time frame: 2 weeks for Histological results to return). 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 4 May 2026.