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

NCT05822895 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 764

Last updated 2026-05-04

No results posted yet for this 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

Conditions

  • Colonic Polyp

Interventions

DEVICE

CADe enabled programme (GI Genius)

CADe enabled programme (GI Genius)

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Sengkang General Hospital

    lead OTHER

Principal Investigators

  • Frederick H Koh, FRCSEd · Sengkang General Hospital

Eligibility

Min Age
21 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-02
Primary Completion
2030-06-30
Completion
2031-12-31
FDA Device
Yes

Countries

  • Singapore

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05822895 on ClinicalTrials.gov