Using AI to Improve Cost-Effectiveness of Colonoscopy Screening
Official title: Saving by Artificial Intelligence for Virtual Endoscopy Biopsy Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology
Run by Istituto Clinico Humanitas · NCT06041945 · Data updated 2026-11-12
This study is testing whether using artificial intelligence during colonoscopies can help doctors tell the difference between harmful and harmless polyps, making screening for colon cancer more effective and affordable.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years and up |
| Sex | All |
| Enrollment | 1800 (estimated) |
| Sponsor | Istituto Clinico Humanitas Academic / other |
| Locations | 2 sites (Rozzano, Milano and 1 other locations) |
| Status | Recruiting |
| Started | September 21, 2023 |
| Main results expected | September 1, 2027 |
| Study ends | September 1, 2027 |
| Registry record updated | October 30, 2026 |
| Trial ID | NCT06041945 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals over 40 years old undergoing colonoscopy for specific indications.
✕Probably not a fit
Patients with a personal history of colorectal cancer, inflammatory bowel disease, or certain genetic conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial investigates the use of artificial intelligence to assist in differentiating between neoplastic and non-neoplastic polyps during colonoscopy. It employs a randomized, multicenter approach with three parallel arms to evaluate the effectiveness of AI-assisted optical biopsy. The study aims to develop a deep learning algorithm that enhances personalized treatment and implements cost-saving strategies in colorectal cancer screening. Additionally, it will conduct cost-effectiveness analyses using real-world data to assess the impact of AI on screening programs.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate and cost-effective colonoscopy screenings, ultimately improving patient outcomes.
How similar studies have gone: Other studies have shown promise in using AI for medical imaging and diagnostics, suggesting potential success for this novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * All \>40 years-old patients undergoing colonoscopy for selected indications Exclusion Criteria: * patients with personal history of CRC, or IBD * patients affected with Lynch syndrome or Familiar Adenomatous Polyposis. * patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale \<2 in any colonic segment). * patients with previous colonic resection. * patients on antithrombotic therapy, precluding polyp resection. * patients who were not able or refused to give informed written consent.
Where it's running
-
Istituto Clinico Humanitas
Rozzano, Milano, Italy Recruiting -
Istituto Clinico Humanitas
Rozzano, Milano, Italy Recruiting
Study contacts
- Study coordinator: Cesare Hassan
- Email: cesare.hassan@hunimed.eu
- Phone: 02-82247385
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.