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RecruitingNCT05822895COPILOTUpdated May 4, 2026

Review of the Impact of a Computer-aided Real-time Polyp Detection System on Adult Colonoscopy

An observational study in Colonic Polyp, sponsored by Sengkang General Hospital. Recruiting at 1 site in Singapore. Open to participants aged 21 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-05-04.

Sponsored by Sengkang General Hospital · Observational

From the registry’s dates

  • Started Jan 2023; still recruiting 3 years 10 months later.
Study type
Observational
Model
Case-control
Time perspective
Other
Enrollment
764
Ages
21 Years to 90 Years
Sex
All
01

Study 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 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

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.

02

Conditions studied

  • Colonic Polyp

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Keywords

  • Colonic polyp
  • colonoscopy
  • artificial intelligence
  • implementation science
03

In context

Colonic Polyps

377 studies on the registry are indexed under Colonic Polyps; 57 are open to participants now.

This study's planned enrollment of 764 is above the median of 411 across 115 observational studies indexed under Colonic Polyps.

Browse Colonic Polyps studies →

Lead sponsor

Sengkang General Hospital is the lead sponsor of 16 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • all adult patients going for colonoscopy in the our institution

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Case-control
Time perspective
Other
Enrollment
764 participants (estimated)
Target follow-up
1 Month
Patient registry
Yes

Groups and cohorts

  • Computer-aided polyp detection

    patients undergoing colonoscopy with CADe enabled programme

    Device: CADe enabled programme (GI Genius)

  • without CADe

    patients undergoing colonoscopy without CADe enabled programme

Interventions

  • DeviceCADe enabled programme (GI Genius)

    CADe enabled programme (GI Genius)

06

What researchers measure

Primary outcomes

  1. ADR

    Adenoma detection rate

    Time frame: 2 weeks for Histological results to return

Secondary outcomes

  1. ADPC

    Adenoma detection per colonscopy rate

    Time frame: 2 weeks, for histological results to return

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05822895
Lead sponsor
Sengkang General Hospital
Collaborators
Medtronic
Responsible party
Koh Hong Xiang Frederick (Consultant Colorectal Surgeon, Sengkang General Hospital) — Principal investigator
First posted
Apr 21, 2023
Start date
Jan 2, 2023
Primary completion
Jun 30, 2030 (estimated)
Completion
Dec 31, 2031 (estimated)
Last update
May 4, 2026

Study contacts

Frederick H Koh, FRCSEd
Contact
frederick.koh.h.x@singhealth.com.sg
+65-84281117
Frederick H Koh, FRCSEd
principal investigator · Sengkang General Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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