NCT05822895 Review of the Impact of a Computer-aided Real-time Polyp Detection System on Adult Colonoscopy
| NCT ID | NCT05822895 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sengkang General Hospital |
| Condition | Colonic Polyp |
| Study Type | OBSERVATIONAL |
| Enrollment | 764 participants |
| Start Date | 2023-01-02 |
| Primary Completion | 2030-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 764 participants in total. It began in 2023-01-02 with a primary completion date of 2030-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Contact & Investigator
Frederick H Koh, FRCSEd
PRINCIPAL INVESTIGATOR
Sengkang General Hospital
Frequently Asked Questions
Who can join the NCT05822895 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 90 Years, studying Colonic Polyp. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05822895 currently recruiting?
Yes, NCT05822895 is actively recruiting participants. Contact the research team at frederick.koh.h.x@singhealth.com.sg for enrollment information.
Where is the NCT05822895 trial being conducted?
This trial is being conducted at Singapore, Singapore.
Who is sponsoring the NCT05822895 clinical trial?
NCT05822895 is sponsored by Sengkang General Hospital. The principal investigator is Frederick H Koh, FRCSEd at Sengkang General Hospital. The trial plans to enroll 764 participants.