Artificial Intelligence-Assisted Colonoscopy in Colorectal Cancer Screening in a General Hospital
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-74
SponsorChirec
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
conventional colonoscopy procedure
Other interventionStudy subjects in this interventional arm will undergo conventional colonoscopy.
artificial intelligence-assisted colonoscopy procedure
Other interventionStudy 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.
Treatment groups
765 Participants
are divided into 2 treatment groupsGroup A: CCP: conventional colonoscopy procedureActive comparator 1 intervention
Group B: ACP: artificial intelligence-assisted colonoscopy procedureActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Adenoma Detection Rate in Conventional versus Artificial Intelligence-Assisted Colonoscopy
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 daySecondary outcomes
1
The difference in the detection rate of colorectal adenomas according to size by group (5 mm/6-9 mm/>10 mm) between a conventional colonoscopic procedure (CCP) and a colonoscopy procedure with AI (ACP).
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 day2
The difference in the detection rate of colorectal adenomas according to the number per group (n=1-2/n= 3-10/n >10) between a conventional colonoscopic procedure (CCP) and a colonoscopy procedure with AI (ACP).
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 day3
The difference in the detection rate of colorectal adenomas based on histology by group (hyperplastic/conventional adenomas/serrated adenomas/adenocarcinoma) between a conventional colonoscopic procedure (PCC) and a colonoscopy procedure with AI.
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 month4
The difference in detection rate of colorectal adenomas based on dysplastic grade by group
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 Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: