Review of the Impact of a Computer-aided Real-time Polyp Detection System on Adult Colonoscopy
ConditionColonic Polyp
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21-90
SponsorSengkang General Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
all adult patients going for colonoscopy in the our institution
Disqualifiers
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 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).
Trial design
Design model
Case-control
Time perspective
Other
Treatments tested in this trial
CADe enabled programme (GI Genius)
DeviceCADe enabled programme (GI Genius)
Treatment groups
764 Participants
are divided into 2 treatment groupsGroup A: Computer-aided polyp detection1 intervention
Group B: without CADe0 interventions
Trial outcomes
Primary outcomes
1
ADR
Adenoma detection rate
Time frame
2 weeks for Histological results to returnSecondary outcomes
1
ADPC
Adenoma detection per colonscopy rate
Time frame
2 weeks, for histological results to returnSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sengkang General Hospital
Lead sponsor
Medtronic
Collaborator
Source ClinicalTrials.gov