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

NCT05822895 | Recruiting DMC FDA Device

• 1 other identifier: 2022/2695
• Study Type: observational
• Target: 764
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Colonic polyp; colonoscopy; artificial intelligence; implementation science

Outcome Measures

Primary Outcomes (1)

• ADR

  Adenoma detection rate

  2 weeks for Histological results to return

Secondary Outcomes (1)

• ADPC

  2 weeks, for histological results to return

Study Arms (2)

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

CADe enabled programme (GI Genius) DEVICE

CADe enabled programme (GI Genius)

Computer-aided polyp detection

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• all adult patients going for colonoscopy in the our institution

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic: collaborator
• Sengkang General Hospital: lead

Study Sites (1)

Sengkang General Hospital

Singapore, Singapore, 544886, Singapore

RECRUITING

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Frederick H Koh, FRCSEd

  Sengkang General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frederick H Koh, FRCSEd

CONTACT

+65-84281117; frederick.koh.h.x@singhealth.com.sg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Colorectal Surgeon

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: April 21, 2023
• Study Start: January 2, 2023
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): December 31, 2031
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)