Artificial Intelligence-Assisted Colonoscopy in Colorectal Cancer Screening in a General Hospital

NCT06792292 · tracked via the Priya Life Science Belgium tracker

Sponsor

Chirec

Phase

Not applicable

Started

2025-02-01

Last updated

2025-01-24

Condition(s) studied

Artificial IntelligenceColonic AdenomaColonic NeoplasmsColonic PolypColonoscopy

Investigational drug(s) / intervention(s)

conventional colonoscopy procedureartificial intelligence-assisted colonoscopy procedure

conventional colonoscopy procedure: Study subjects in this interventional arm will undergo conventional colonoscopy.

artificial intelligence-assisted colonoscopy procedure: Study subjects in this interventional arm will undergo colonoscopy done with a commercially-available module that uses artificial intelligence to highlight suspected polyps on the screen during colonoscopy. This module also attempts to characterize the detected polyp as adenomatous or not. The detection and characterization of polyps is in real time, during the procedure.

Study summary

Cancer can develop in the colon, or large bowel. Examination of the colon with a tube fitted with a camera is called a colonoscopy.

Colonoscopy allows detection of small growths in the colon, called "polyps". Polyps can often be removed during colonoscopy. Some of these polyps are called adenomas and can become cancer after several years.

A good colonoscopy aims to find and take out as many of these polyps as possible.

A quality indication of colonoscopy is the "adenoma detection rate" (ADR). It should be high, meaning many polyps are detected and taken out.

New artificial intelligence devices to assist colonoscopy seem to increase the ADR, and maybe help prevent cancer even better than normal colonoscopy.

The goal of this clinical trial is to compare the ADR when using standard colonoscopy to the ADR with artificial intelligence (AI)-assisted colonoscopy.

Eligibility

Sex

ALL

Min age

45 Years

Max age

74 Years

Healthy volunteers

Accepted

Inclusion criteria: * Patient (woman or man) candidate for a screening colonoscopy - Age: 45 to 74 years included * Absence of inflammatory bowel disease * Absence of significant digestive symptoms indicating colonoscopy (i.e. screening is the only indication for the examination) * Patient able to understand the concept of the study and agreeing to participate Exclusion criteria: * Patient outside the inclusion age * All exclusion criteria for a colonoscopy. * The indication for colonoscopy is not simple screening; for example, assessment of anemia, rectal bleeding, weight loss or abdominal pain. * Patient's refusal to participate, or patient's inability to understand the study concept * Any patient with major psychological or psychiatric disorders.

Primary outcome measure(s)

Adenoma Detection Rate in Conventional versus Artificial Intelligence-Assisted Colonoscopy — 1 day
The main objective of this study is the difference in the detection rate of colorectal adenomas in individuals over 45 years old during colonoscopies for colon cancer screening between a conventional colonoscopy procedure (CCP) and a colonoscopy procedure with AI (ACP).

Trial sites (1)

Facility	City	Region	Status
Hopital Delta Chirec	Auderghem	Brussels Capital

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06792292 on ClinicalTrials.gov ↗ ← All trials in Belgium