Ignite Creation Date:
2025-12-24 @ 3:19 PM
Ignite Modification Date:
2026-01-02 @ 6:37 AM
Study NCT ID:
NCT06792292
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-24
First Post:
2025-01-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Artificial Intelligence-Assisted Colonoscopy in Colorectal Cancer Screening in a General Hospital
Sponsor:
Chirec
Organization:
Study Overview
Official Title:
Real-World Experience of Artificial Intelligence-Assisted Colonoscopy in Colorectal Cancer Screening in a General Hospital: A Single-Center Cohort Phase IV Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Delta-AI
Brief 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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: