Hopital Delta Chirec
Auderghem, Brussels Capital, 1160, Belgium
Location contact
Erik Francois, M.D.
CONTACT
Erik Francois, M.D.
PRINCIPAL_INVESTIGATOR
Philippe Langlet, M.D.
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06792292
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.
Trial opening soon.
Get Notified45 year–74 year
All sexes
Interventional
Not applicable
Auderghem, Brussels Capital, 1160, Belgium
Erik Francois, M.D.
CONTACT
Erik Francois, M.D.
PRINCIPAL_INVESTIGATOR
Philippe Langlet, M.D.
PRINCIPAL_INVESTIGATOR
The colon is a part of the bowel where colon cancer can develop.
It is possible to prevent colon cancer by doing a screening test called a colonoscopy.
The colonoscopy procedure allows detection of "polyps" which can often be removed during the procedure. 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.
Patients who are scheduled to have screening colonoscopy and who agree to participate, and are aged 45 years or more, will be randomly assigned to receive either standard colonoscopy or AI-assisted colonoscopy.
The main objective of this study is the difference in the ADR between a conventional colonoscopy procedure and an AI-assisted colonoscopy procedure.
Secondary objectives will compare the 2 groups (conventional colonoscopy and AI-assisted colonoscopy) regarding polyp size, polyp quantity, polyp histology (laboratory analysis of the polyp that was taken out), polyp dysplasia grade (how close the polyp is to cancer), polyp location in the colon, endoscopist experience (older or younger doctor), time of day and colonoscopy preparation quality (how clean the bowel is).
With these results we can show that AI-assisted colonoscopy is useful or not to help better prevent colon cancer.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Study subjects in this interventional arm will undergo conventional colonoscopy.
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.
Time frame: 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).
Time frame: 1 day
Detection rate of diminutive, small, and large polyps will be compared between a conventional colonoscopic procedure (CCP) and a colonoscopy procedure with AI (ACP).
Time frame: 1 day
The number of adenomas detected during the procedure will be compared between a conventional colonoscopic procedure (CCP) and a colonoscopy procedure with AI (ACP).
Time frame: 1 month
Adenomas have different histologic types. After obtaining histology, the detection rate of the various histologic types will be compared between a conventional colonoscopic procedure (CCP) and a colonoscopy procedure with AI (ACP).
Time frame: 1 day
The difference in detection rate of colorectal adenomas based on dysplastic grade
by group (conventional or serrated adenomas/low-grade dysplasia/high-grade dysplasia/adenocarcinoma) or Narrow Band Imaging International Colorectal Endoscopic (NICE) (stages 1, 2 or 3) classification or Japan Narrow Band Imaging Expert Team (JNET) classification (stages 1, 2A and 2B, or 3) between a conventional colonoscopy procedure (CCP) and a colonoscopy procedure with AI (ACP).
Time frame: 1 day
Location of adenomas will be compared between a conventional colonoscopic procedure (CCP) and a colonoscopy procedure with AI (ACP).
Time frame: 1 day
The difference in the detection rate of colorectal adenomas according to experience by group (Colonoscopists aged 45-55 years/56-65 years/>66 years) between a conventional colonoscopic procedure (CCP) and a conventional colonoscopic procedure (CCP) colonoscopy with AI (ACP).
Time frame: 1 day
The difference in the detection rate of colorectal adenomas depending on the time of day (before 11:00/between 11:00 and 15:00/after 15:00) and the number of colonoscopies (Colonoscopy from 1 to 6 per half-day) per group (hyperplastic/conventional adenomas/scalloped adenomas/adenocarcinoma) between a conventional colonoscopic procedure (PCC) and a colonoscopy procedure with AI (ACP).
Time frame: 1 day
The difference in the adenoma detection rate according to the quality of colonic preparation will be compared between a conventional colonoscopic procedure (CCP) and a colonoscopy procedure with AI (ACP).
Contact information is provided by the study sponsor or research team.
Erik Francois, M.D.
CONTACT
Philippe Langlet, M.D.
CONTACT
Chirec
Other
Real-World Experience of Artificial Intelligence-Assisted Colonoscopy in Colorectal Cancer Screening in a General Hospital: A Single-Center Cohort Phase IV Study
Acronym: Delta-AI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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