Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05822895

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Colonic Polyp Colonic Polyps Intestinal Polyps Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sengkang General Hospital

Singapore, 544886

Location status: Recruiting

Location contact

Frederick H Koh, FRCSEd

CONTACT

[email protected]

84281117 ext. 65

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all adult patients going for colonoscopy in the our institution

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

Treatment and study plan

CADe enabled programme (GI Genius)

Device

CADe enabled programme (GI Genius)

Primary outcomes

  1. ADR

    Time frame: 2 weeks for Histological results to return

    Adenoma detection rate

Secondary outcomes

  1. ADPC

    Time frame: 2 weeks, for histological results to return

    Adenoma detection per colonscopy rate

Study contacts

Contact information is provided by the study sponsor or research team.

Frederick H Koh, FRCSEd

CONTACT

[email protected]

+65-84281117

Sponsors and collaborators

Lead sponsor

Sengkang General Hospital

Other

Collaborators

  • Medtronic

Registry information

Official study 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

Acronym: COPILOT

Important dates

Study start
2023
Primary completion
2030
Study completion
2031
First posted
Apr 21, 2023
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.